The key to prevention of both PUs and DFUs is early identification of at-risk patients and prompt implementation of effective targeted prevention strategies. Prevention is targeted at the risk factors and underlying conditions that make ulceration more likely. These strategies are the same for adults and neonates, although some skin sites are more susceptible in neonates, for example, the occipital area. It is important to note, there is no one-size-fits all solution for either PU or DFU prevention; both must be tailored to the individual patient.

Pressure ulcer prevention

      The US AHRQ has published a detailed tool kit that guides health professionals in PU prevention. 18 Where prevention strategies are not already implemented, or existing strategies are under review, it is recommended that the tool kit is consulted. All patients are potentially at risk of developing a PU. The purpose of a risk analysis is to identify those at highest risk and where early skin changes have taken place, and to target preventative interventions to them. The risk analysis should be conducted as soon as possible, and for inpatients no later than six hours after admission.107 The risk analysis will identify risk of PU formation and any areas of ulceration that already exist.

      The starting point is care standards, as laid out in guidelines. The most widely-used are those of the EPUAP, NPUAP and PPPIA.7 Others include those from the National Institute for Health and Care Excellence (NICE) in the UK.107 The UK NHS suggests following a five-step process for prevention and treatment of PU, known as the SSKIN Bundle,108 which follows the main principles of PU prevention and treatment. The acronym refers to: surface that the patient is on, skin inspection conducted early, keep the patient moving, incontinence and moisture management to keep the patient clean and dry, and nutrition (diet and fluids).

Pressure reduction, redistribution and removal

      For individuals at risk of a PU due to activity and mobility problems, there are pressure redistribution options available, namely, continuous low pressure devices, such as high-specification foam, and high-tech surfaces (low air loss, alternating or air fluidised). Selection of the surface should be based on an assessment of the individual’s mobility status and general skin condition. If these surfaces are not available, the frequency of repositioning should be considered, as this will need to be increased to protect the individual from the adverse effects of pressure and shear forces.

      Mattresses may be augmented by additional pressure relieving and redistribution foam pads. Pressure reduction and redistribution may be targeted at a specific at-risk anatomy, for example the heel, byproducts that protect the heel in a pressure redistributing boot. Several such products are available, including the Heelift Suspension Boot (DM Systems, UK; Position Health, US), Devon Boot and Heel Protector (Aria Medical), HeelMedix (Medline Industries), Repose Foot Protector (Frontier Medical), Mölnlycke DAP-600Z Fluidised Heel Protector Boot (Mölnlycke Health Care). Patients who are lying in a position where there may be compression of the common peroneal nerve (i.e. lower leg leaning against rails by the side of the bed, or against a wall or even the hand control panel) are prone to developing nerve palsy and foot drop. While the protective boot may help keep the limb in a more neutral position, not all facilities/regions have protective boots available. Hence, health professionals should be aware of the possibility of developing foot drop and be on alert, noting the patient’s position to prevent the development of nerve palsy.

      Pressure between the legs may be managed using products that fit between the legs and keep them separated, for example Devon Utility Pad (Aria Medical). If pillows are used to manage pressure, care must be taken to ensure correct positioning, to avoid undue pressure over any bony prominence. Also note, they increase body temperature and could cause higher levels of moisture on the skin. Furthermore, pillows may increase body temperature.

      The tissue at-risk may be targeted with pressure-relieving and redistributing patches that are placed directly on the at-risk site. Examples include Aderma (Smith & Nephew), and KerraPro (Crawford Healthcare). Some dressings specifically designed to manage the risk of PU formation are available, for example Mepilex Border (Mölnlycke Health Care) and foam dressings are often intended to manage the risk of PU formation.

      Repositioning the patient is a critical part of removing pressure. Patients at-risk of PU formation should be repositioned every two to four hours, so that they lie or sit with weight supported on a different part of the body. A number of products are available to ensure that the patient remains in the desired position. These include shaped blocks and foams that are placed against the patient to prevent rolling or movement back onto the vulnerable skin site. Examples include Devon Utility Pad (Aria Medical), Mölnlycke Z-Flo Fluidised Positioner Z3 and Z4 (Mölnlycke Health Care) and wedges and foams from a number of companies.

      In practice, it is common not to have positioning aids and, in this instance, pillows can be used to help position the patient. Patients who are able to should be advised to reposition themselves no longer than every six hours.107 In patients who cannot be repositioned because of their medical condition, where available, a high-specification pressure relieving mattress such as a low air loss or fluidised bed should be used. Where such a mattress is not available, advice should be sought from the MDT; perhaps tilting rather than fully repositioning may be of benefit. However, the risk of PU development due to the inability to reposition should be discussed with the patient/relatives and MDT, where available, and clearly documented in the clinical notes.

Friction and shear reduction

      Friction deforms skin and induces internal tissue stress when the patient moves, or is moved, by sliding on a surface such as a bedsheet. Friction is reduced by placing a low-friction interface between the skin and the surface, or by absorbing some of the deformation in the interface. Friction-reducing products should be used where the risk of friction-induced shear stress has been identified. Examples of friction-reducing interfaces include slide sheets, which are distributed by several companies, and low-friction bootees, undergarments and pillow cases (APA Parafricta). Where low friction interfaces are not available, great care should be taken when repositioning and moving of the patient.

Skin care

      Barrier creams should be used to protect against moisture-associated skin damage (MASD). Massaging or rubbing the skin should not be performed, to prevent PUs: hand movement used to apply protective creams should be enough only to ensure even spread of the cream. Sprays and dressings are also suggested as they are transparent and/or quick drying on the skin, examples include, Cutimed Protect (BSN medical), Cavilon (3M Ltd) and Opsite (Smith & Nephew).

Nutrition

      Where nutritional deficiency has been identified, and where available, a nutritionist should assess the patient’s dietary needs and advise on improvements to minimise the effect of malnutrition.

Diabetic foot ulcer prevention

      All patients with diabetes and loss of protective sensation (diabetic peripheral neuropathy—DPN) are at risk of developing a DFU. The purpose of a risk analysis is to identify those at highest risk, to stratify the risk, and to target preventative interventions optimally. 

      The start point for prevention of DFU is care standards, as laid out in guidelines. The most widely used worldwide guidelines on preventing DFU are those of the IWGDF.109 Other guidelines include those prepared by NICE,28 the Task Force of the Foot Care Interest Group of the American Diabetes Association,83 the International Diabetes Foundation (IDF),110 Saskatchewan Ministry of Health (MoH),111 and the Wound Healing Society.112

The key components of DFU prevention that should be followed include:

● Nail care

● Emollient use

● Footwear

● Daily self-examination of the feet

● Not walking in bare feet

● Callus debridement

● Checking footwear and hosiery before wearing

● ‘Breaking shoes in’ never to be attempted

● No hot water bottles

● Checking bath and shower temperature

● Avoidance of home remedies e.g. corn plasters

● What to do and the appropriate person to contact if foot problems develop.

      The Task Force of the Foot Care Interest Group of the American Diabetes Association83 and Saskatchewan MoH recommend the approach laid out in Table 4 to stratifying and managing the risk of DFU formation. The health-care services available to all persons living with diabetes should include the following (adapted from Saskatchewan MoH guidelines and others):111

● Daily foot inspection/examination and risk assessment

● Nail care

● Callus care

● Skin care

● Foot hygiene

● Podiatric management

● Pressure reduction to foot (offloading).

      Appropriate selection of protective footwear includes:

● Commercially available shoes designed for the diabetic foot may be adequate for low-risk patients

● Added-depth shoes should be recommended for high-risk patients who have DPN, vascular insufficiency and/or mild-to-moderate foot deformity (a custom-moulded inlay may be needed)

● Custom-moulded shoes with custom inlays should be recommended for high-risk patients with advanced deformity

● Patients should be advised not to walk at any time without wearing protective footwear.

      Further information on footwear for patients with diabetes can be found in updated recommendations from Diabetic Foot Australia.113

      In addition to the measures that the patient should adopt (Table 4), the temperature of the foot should be assessed and, when higher than normal, the patient should be referred to a health professional. High temperature may indicate tissue breakdown and/or infection. Foot inspection may be assisted by the use of a mirror. However, patients with diabetes may have impaired vision because of retinopathy and should be assisted by a helper who has been educated in how to inspect the foot.

Management

Navigating the patient through the pathway

      The first step is to identify a clinician who is the ‘wound care navigator’ (WCN). The job title of the WCN is less important than the ability to fulfil the requirements of the role. The role of the WCN is to conduct an appropriate assessment and refer quickly where needed. The job function of the WCN will vary from country to country, but the person should be trained and able to do the following:

● Assess the patient to identify those at risk of PU or

DFU formation

● Take a patient history

● Identify the basic characteristics of the ulcer (location, size, depth, presence of necrosis, pain, signs of infection)

● Conduct simple tests to identify if an ulcer is most likely to be a PU or a DFU, particularly when the ulcer is on the heel (pulse palpation is crucial)

● Identify the additional tests and assessments required to fill in the gaps in knowledge and competencies

● Identify the appropriate care pathway and clinician to whom the patient should be referred

● Be aware of the urgency of the referral (i.e. a patient with ascending cellulitis, gas gangrene or necrotising fasciitis needs to be referred immediately).

      Additional skills required may include: administer a monofilament test and/or vibration perception test; administer ABPI test; perform a Doppler ultrasound; and wound management.

      The level of training and competence of the WCN may be at a basic level. Where competence does not include conducting pulse palpation and/or a basic Toe Touch Test, the WCN should know how, and to whom, to refer the patient. At the basic level, no specialist equipment is required to assess the patient. In the case of a possible heel PU or DFU, sensation and neuropathy is assessed by the Toe Touch Test and vascular status is assessed by pulse palpation.

Wound management

      Where possible clinically, a PU or DFU should be managed to ensure timely ulcer closure. Standards of care specific to the management of PU and DFU have been published by a number of organisations. 7,53,107,108,111,114,115 However, where available, local guidelines should be followed.

      There are also a number of generic guidelines on principles of best practice in wound management, for example, wound bed preparation: TIME and MOIST have also been published.116–118 These provide information on how the major areas that must be considered when preparing the wound bed to aid healing.

      The principles of TIME are used to guide health professionals on what to assess and treat in the wound bed:

● Tissue status: viable, non-viable, deficient

● Infection or Inflammation

● Moisture balance

● Epidermal margin; non-advancing or undermined.

      Over the years, these principles have been modified to include other markers, such as TIME-H, which includes a healing score. Another variation on the TIME principle, recently developed by the German wound association, Initiative for Chronic Wounds (ICW) e.V. is MOIST: 118

● Moisture balance: exudate management, ensure that the wound is neither too moist nor too dry

● Oxygen balance: in the pathophysiology of chronic wounds, hypoxia plays a decisive, central role in nearly all types of wounds

● Infection control: all antimicrobial strategies in wound therapy regimens

● Support: if, despite an apparently adequate therapy, wounds do not heal, specific wound care agents can be used temporarily

● Tissue management: all measures of conditioning the wound bed, for example, neutral wound dressings, biosurgery or physical aids such as negative pressure wound pressure (NPWT), electricity, plasma, or ultrasound.

      MOIST covers the general principles of TIME and includes a section on oxygen balance, which if compromised will hinder wound closure and may be of particular importance in ischaemic DFUs.

General principles of wound management

      The general principles of effective wound management, embodied in all guidelines in slightly different ways, should be implemented for PU and DFU. The principles common to all guidelines include the following steps:

1. Assessment and diagnosis

2. Development of care plan

3. Management of the underlying condition and

causes (including offloading for DFUs and pressure

relief for PUs)

4. Management of exudate

5. Management of bioburden (infection and biofilm)

and inflammation

6. Debridement

7. Managing hypoxia

8. Nutrition and hydration

9. Monitor progress and adjust care plan

10. Prevent recurrence.

      In the next section, the processes (excluding assessment and diagnostics) and procedures recommended for the management of the wound, including its underlying condition and causes, to maximise the probability of healing, are described. The flow in Fig 4 is a flowchart showsthe basics of these management and treatment pathways.

      These steps may be achieved with products that range from low-cost and basic to the high-cost and advanced. Care should be delivered using products that have evidence-based data on their effectiveness in the local population. Effectiveness may be measured by clinical efficacy and health economic analysis. Health economics in particular are specific to the patient population and health-care delivery system in which the analysis was conducted. Assessment and diagnosis has been covered in detail in section 3. Tables 5 and 6 show areas to consider when treating a PU or DFU.

Care plans

      A care plan describes how the patient will be managed, based on the outcomes of assessment and diagnosis. The plan covers the care that needs to be delivered, the procedures, processes and competencies required to deliver the care, and where treatment will take place. Referral is part of the care plan (section 3), because it requires an assessment to identify what needs to be delivered and the competencies, and, therefore, which health professionals should be involved. Managing the underlying condition and causes Delayed wound healing is a consequence of a wound being stuck in the inflammatory stage of the healing cycle. Trapped in this inflammatory phase, there is an excess of inflammatory molecules, including inflammatory cytokines, free radicals, and proteases such as matrix metalloproteinases (MMPs) and tissue inhibitor matrix metalloproteinases (TIMPs) , which become harmful to the wound bed and periwound area, disrupting wound healing.119,120

      The molecular basis of incomplete wound healing and the change from an acute to a chronic wound is a major focus of attention in wound healing research in patients with diabetes. DFUs have a prolonged inflammatory phase with fibroblast dysfunction, impaired neovascularisation, and increased concentrations of MMPs. This excess of MMPs alters the wound healing process through degradation of the extracellular matrix (ECM), affecting both the control of the activities of various effector proteins such as growth factors and the deposition of new ECM.119,120 DFUs often fail to heal because of persistently high levels of pro-inflammatory cytokines in the wound, which induce high levels of MMPs and subsequently destroy growth factors, receptors and matrix proteins essential for wound healing. MMPs are also responsible for the controlled fragmentation of the basal membrane, induction of inflammation and angiogenesis, as well as for epithelialisation. Modulation of MMPs in the wound area, as well as other regulating factors of wound healing (e.g. PDGF, FGF, EGF, cytocines, etc.), could be a benefit in the treatment of chronic wounds.

Pressure ulcers: pressure and friction/shear should be managed with methods that achieve pressure reduction and redistribution. These are generally the same as those used for PU prevention and include pressure-relieving and redistributing surfaces, anatomy-specific products such as heel protection boots, dressings, and repositioning the patient.

      Moisture management should include barrier creams, and methods to contain and control incontinence. An active PU is itself a source of moisture. Please refer to the section on ‘managing exudate’ for more detail.

      Local treatment guidelines, where available, should be used; however, examples include using the SSKIN bundle with treatment tailored to the condition of the wound. 

Diabetic foot ulcers: blood flow, neuropathy and foot deformity leading to pressure and infection should be managed. These are components of VIPS.

      As discussed earlier, every patient with a DFU should have a vascular assessment. If a patient has tissue loss and an ABPI of ≤0.90, that will require vascular review. Similarly, tissue loss and a systolic toe pressure of <50mmHg that necessitates vascular review as a TBI of <50mmHg has been associated with impaired healing. Other suggested examinations before referral are: pulse palpation, Doppler isonation, with monophasic/ biphasic/triphasic sound. With Doppler isonation, a monophasic pulse would be abnormal and necessitate further assessment/referral, as the presence of a monophasic Doppler is considered indicative of PAD.

      Neuropathy leads to inability to sense pain in the foot. Patients with neuropathy may wear shoes that are too tight, because they cannot feel when they do not fit correctly. Furthermore, loss of sensation means that a wound or object in the shoe that could cause injury goes unnoticed. Coupled with repetitive trauma from walking, this will cause ulcer formation. Furthermore, deformity causes high pressure points, which are vulnerable to damage. All patients with neuropathy and a DFU should wear correctly fitted offloading footwear. Amputation leads to abnormally high pressures underneath the foot and requires offloading customised to the foot shape.

      The optimal offloading method associated with the highest rate of full DFU closure in the shortest time is non-removable TCC (an example is Delta-Cast Conformable, BSN medical).121–124 The foot is closely fitted with a cast that distributes pressure over the entire plantar surface of the foot. TCC application is highly skilled and should be done by health professionals fully trained in the technique, to minimise the likelihood of rubbing, causing additional damage and to optimise pressure redistribution. In general, the initial change will take place 2–3 days after the first cast is applied (to ensure that everything is alright). Afterwards, the cast will generally be changed about once a week, or as determined by the health professional, to accommodate any reduction in limb size as oedema reduces and to inspect the skin and foot for damage. A TCC alternative that is easier to apply, but still requires training, is the TCC-EZ (Derma Sciences). This product may be considered instead of a traditional TCC.

      Where the competency for traditional non-removable TCC or TCC-EZ is not available, other removable footwear options for offloading should be used when appropriate to the health-care system and the patient’s preferences. These include knee-high walkers, forefoot shoes, and custom-made temporary shoes. DFUs heal less well with removable offloading compared with non-removable TCC, because devices are often removed and not used when the patient walks. Non-use reduces the offloading delivered to the foot, impeding effectiveness. It is important therefore to ensure that the patient will wear the offloading device at all times when ambulatory, even in ‘safe’ environments such as the home. The offloading must be fitted with an interface between the foot and the internal surfaces of the device to ensure optimal pressure redistribution. Where offloading devices are not available, felted foam should be used. An alternative is complete pressure removal with crutches, walkers, wheelchairs or foot elevation. Where possible, all neuropathic and ischaemic DFU should be managed with offloading.

      Where offloading is not successful, further options, as required after assessment by the MDT, are required, such as surgical intervention to correct deformities.

Management of exudate

      Exudate from a chronic wound not only increases skin moisture when in contact with the surrounding skin, but also contains destructive biological molecules, including protein-degrading enzymes that may harm the wound bed and periwound skin. It is important to minimise the amount of exudate that comes into contact with skin and the duration of contact for both PU and DFU. Exudate is generally managed by dressings or NPWT.

      Dressings provide a cover for the wound, to help avoid contamination of the ulcer contamination from exogenous sources and the dispersal of organisms from the wound to the environment. There is widespread agreement that the ulcer should be maintained in a moist, warm environment to encourage healing. Some authorities advise that gauze should not be used, and that the least expensive dressing that fulfils the clinical requirements should be used. Local guidelines should be followed. Dressing selection depends on several factors, including:

● The site and size of the ulcer

● The amount and type of exudate

● The stage of healing of the ulcer and predominant tissue type

● The integrity and condition of the surrounding skin

● The quality of the patient’s skin

● The patient’s tolerance of adhesives

● Pain

● Comfort and QoL

● The anticipated frequency of dressing change

● The need for topical antimicrobial management of the ulcer

● Compatibility with other elements of the overall care plan

● Cost

● Availability and formularies

● Local guidelines.

      Management of bioburden (infection and biofilm) and inflammation Bioburden, and biofilm in particular, is believed to impede healing.125 At least 60%, and possibly all, of chronic wounds have mature, established biofilm on the surface and in deeper tissues126,127 and it is challenging to diagnose clinically.126 There are no biofilm-specific markers and it cannot be seen by the naked eye. The diagnosis that biofilm is contributing to impeded healing is therefore made by eliminating other factors that may impede healing. When assessment suggests that biofilm contributes to impaired healing, early intervention is recommended. New regimens are being suggested, such as biofilm based wound care (BBWC), 126,127 which aim to disrupt and suppress biofilm, allowing local antimicrobial agents to kill the bacteria.

      However, a gradually de-escalating regimen, informed by assessment of inflammation and wound healing, is recommended. Starting on days 1 to 4, aggressive debridement, topical antiseptics and systemic antibiotics, management of underlying host factors, and profiling microorganisms using genetic methods are recommended.126,127 Treatment is de-escalated with regular debridement and cleansing as healing improves. Genetic profiling of microorganisms is highly specialised and available in a few institutions. Where required, standard microbiological evaluations may be conducted, using swab, or preferably biopsy, specimens.

      Microbiological analysis is used to direct antibiotic therapy, not to diagnose infection. Many guidelines contraindicate systemic antibiotics where clinical infection is absent. Local guidelines should be followed. Antimicrobial agents do not improve healing in wounds where bioburden is not the cause of impaired healing. Their effect is to help manage bioburden, which in turn impairs healing. Antimicrobial dressings are not generally recommended for preventing secondary infection, but may be recommended for mild clinical infection. Topical antiseptics/antimicrobials should be used where a microbiological cause of impaired healing has been identified. They should be used for up to two weeks, and the wound regularly re-assessed. If healing has improved, topical antiseptics/antimicrobials should be stopped and non-antimicrobial dressings used. If healing has not improved, the wound should be assessed to decide whether to continue the current antiseptic or to switch to a different antiseptic. Assessment should include factors other than ulcer bioburden that may be impairing healing.

      Clinically-diagnosed infection should be managed using systemic antibiotics. Topical antibiotics are not recommended, and are associated with increased risk of development of antibiotic-resistant organisms. Antibiotics should be selected based on ulcer specimens and antibiograms. In severe infection, particularly in the DFU, immediate empiric broad-spectrum parenteral antibiotics should be administered as per local guidelines. Once the sensitivity data are available from the microbiology service, antibiotics should be customised to the patient. Duration of antibiotic therapy should be according to clinical assessment outcomes. Antibiotic stewardship guidelines should be followed. Management of infection includes surgical drainage of abscesses and excision of infected bone.

      Microbiological specimen collection may be achieved using one of a number of methods, according to local practice and guidelines. General principles include:

● Specimens should be collected before starting antibiotics

● The ulcer should be debrided and cleaned before specimen collection

● Specimens should be transferred quickly to transport medium to preserve the specimen

● The request should include tests for aerobic and anaerobic organisms and antibiotic sensitivity.

      Sampling methods include pus collected from the deepest part of the wound, swabs (a number of swabbing methods are available), aspiration, tissue biopsy, and, for osteomyelitis, bone biopsy. Osteomyelitis should be suspected if a probe or finger touches bone. Antibiotic therapy should be continued for up to six weeks for osteomyelitis. Additional diagnostic procedures for osteomyelitis such as X-Ray, MRI, CT scanning and other advanced methods may be used where available. Where systemic infection is suspected, blood cultures should be done. For further reading, see Harries et al.117 which explains the different forms, infection prevention and management.

      Chronic inflammation should also be managed. Kick starting a wound stalled in the inflammatory stage into healing by modulating excess inflammatory mediators should be considered. Impaired neovascularisation and excess of MMPs are two major factors impeding the healing of chronic wounds, especially the ones encountered with vascular insufficiency.128,129 Compounds have been shown to modulate MMP levels130 and have effects on other cellular molecules, including growth factors and neovascularisation (sucrose octasulfate)132 and other proteases and cytokines (collagen ORC).133 Modulation of these signals has been shown to improve wound closure of DFUs,134–136 demonstrating the potential of these healing enhancers.

Debridement

      Debridement is an important component of a good standard of wound management. Debridement removes calluses, unwanted and dead tissue, and slough from the wound. It enables accurate assessment, helps drainage, improves healing, removes biofilm, and a reservoir of potential infection. Debridement may be accomplished by a number of methods, which should be selected according to clinical assessment, the needs of the wound, local practice, and availability of equipment and competencies. Debridement methods include:

● Autolytic: hydration of tissue to allow natural host proteolytic enzymes to remove devitalised tissue. Hydration is obtained in dry tissue using hydrogel or honey

● Enzymatic: exogenous proteolytic enzymes used to dissolve devitalised tissue. The efficacy of enzyme debridement is considered unproven by some authorities

● Larval: ‘biosurgery’. Use of greenbottle fly larvae to remove devitalised tissue selectively. Cannot remove callus. Larvae must be prepared by specialist suppliers

● Surgical sharp: invasive debridement with surgical instruments under anaesthesia for sensate patients; anaesthesia may not be required in neuropathic DFU. Surgical debridement should be conducted only by competent practitioners. A curette may be used to scrape loose material gently off the wound. Pain management may be required

● Hydrosurgery: surgical debridement with pressurised water jet to dislodge and remove devitalised tissue

● Ultrasonic:137,138 ultrasound and fluid to remove devitalised tissue mechanically. Relatively recent introduction means it may not be widely available.

      Health professionals must be able to distinguish between tissues and structures to avoid damaging the local anatomy when debriding and have a high level of clinical decision-making to control the extent of debridement. An old mechanical technique known as ‘wet-to-dry’, in which a wet gauze is allowed to dry on the wound and then pulled off, is no longer recommended, because it causes pain for the patient and removes tissue indiscriminately, causing trauma.

      For PU, debride only when clinically indicated by the presence of devitalised tissue or slough and when there is adequate tissue perfusion to the wound. Any of the debridement methods may be used, taking into account the size and depth of the PU, clinical requirement for speed of debridement, patient tolerance, especially with surgical debridement, comorbidities and the care plan, which may include grafting, for which a clean recipient wound bed is essential. Surgical debridement is appropriate for PU with extensive necrosis, advancing cellulitis, crepitus, fluctuance, and/or sepsis secondary to ulcer infection. Larval debridement may be considered where sharp debridement is contraindicated. 

      For DFU, debridement has been shown to improve DFU healing.139 Where available, the widely-accepted standard is sharp debridement using scissors or scalpel and forceps. Vascular status should be confirmed before debridement and compromised tissue should not be surgically debrided. Non-surgical debridement should be used where the required competencies are not available or in patients who cannot tolerate surgery. Larval debridement may be considered, if it is available.

Managing hypoxia

      Patients with diabetic foot syndrome often display a functional vascular impairment caused by a thickening of the basal membrane and endothelial capillary swelling. As a consequence of the developed neuropathy, the endothelium-dependent regulation of the vascular lumen is affected by nitric oxide (NO) and the neuronal regulation of the precapillary arterioles is deregulated. Due to such dysfunctions, an adequate reaction in the foot to an injury like an increased blood flow in response to the high demand of oxygen and nutrient cannot be achieved. Although the feet of patients with diabetes seem phenotypically healthy, such underlying structural and molecular changes may prevent a sustained oxygen supply when needed after an injury.118 An important consideration in physiologic wound healing is oxygen supply and oxygen tension in the wound bed. The oxygen balance in wounded tissue is an important challenge, as it affects all other aspects required for appropriate wound healing.118

Nutrition and hydration, glycaemic control

      Good nutritional status is required for optimal healing. Patients should be assessed by a nutritionist or other health professional competent to conduct a nutritional assessment and diet, and fluid intake adjusted according to clinical need.

The following tools could be employed to assess status:

● Malnutrition Screening Tool (MST)

● Mini Nutritional Assessment (MNA) – short form and long form

● Malnutrition Universal Screening Tool (MUST)

● Subjective Global Assessment (SGA)

      Note: in developing countries, the dietitian and not the nutritionist perform the dietary assessments using their Dietitic Care Notes (DCN).

Monitor progress and adjust care plan

      The ulcer should be inspected and assessed at least weekly to monitor progress. Where clinical improvement is not seen, regular assessment will indicate an alternative care plan, which should be documented and implemented. An accepted time point is 4 weeks following the start of DFU treatment when the ulcer should be assessed using the methods previously described. Healing progress measured as area reduction and wound bed improvement at this time point is generally regarded as an indicator of the likelihood of complete ulcer healing.140-143 In cases where the ulcer size has reduced by <50% at 4 weeks, an alternative care plan should be considered. The new care plan may need referral for tests and evaluations or other more advanced interventions where local guidelines recommend them. These may include advanced therapies or surgical procedures for debridement, grafting or vascular reconstruction. In the US, the Centers for Medicare and Medicaid Services (CMS) uses the 4-week statistic as a trigger for reimbursement of advanced therapies. Other jurisdictions advise not using some advanced therapies, because the health economic advantage has not been adequately proven.

      Where the expected clinical progress is met, treatment should continue according to the care plan.

Prevent recurrence

      Prevention has already been covered in detail in this section; however, it is worth mentioning certain treatments should be performed until complete wound closure, to avoid recurrence of infection/ slough/exudate/pain or to stall wound healing.144 The main causes for recurrences in DFUs are: location of the ulcer (plantars surface and specially beneath first metatarsal head), use of non-appropriate shoes, presence of foot deformities and previous amputation.

Technologies and therapies to consider

      Treatment of PUs and DFUs is not effective in every patient; some wounds do not heal in a timeframe consistent with expectations and clinical experience. When this happens, alternative approaches are required, including new or advanced therapies. This modification of the care plan must be founded on objective information. A stepwise approach based on detailed patient assessment should be adopted.

      This section looks at some of the options and alternatives available, recognising that these options are not available in all countries and that, where they are available, national guidelines and payment systems may not cover their use. Table 7 shows a number of options. It should be noted that the therapies suggested here and in the standard care options described above reflect variations in preferences worldwide. For a full review of new advanced therapies, see the EWMA document, Advanced therapies on wound management.146

What to do if not healing with standard care

      If standard care has failed to lead to a reduction in the wound size ≥50% over four weeks,140-143 the first step is a thorough and detailed reassessment of the ulcer and the patient. The accuracy of the original diagnosis should be validated and the treatment choices reviewed. Has the underlying condition changed? New tests may be required. For example, where a basic test such as pulse palpation was carried out, would better information be provided by a more advanced test such as a full vascular work up, if available? Perhaps a basic IpTT or vibration perception threshold test gave inaccurate information. Would a more detailed analysis of nerve conduction provide better diagnostic fidelity? Where a diagnosis of uninfected was made, would a white blood cell count or C-reactive protein (CRP) test give more helpful information? Is it inflammation? Is there something about the wound, such as carcinoma, that was previously not detected?

      Once the assessment has provided up-to-date information and it is confirmed that the previous standard of care was correct, it may be appropriate to consider other therapies and more aggressive treatment regimens. A benchmark for making a decision on switching to therapies is the healing response after four weeks’ care with best practice.140-143 If the wound has not decreased by ≥50% from the start of treatment, then a switch may be indicated.

      The advancement may be escalation of the intensity of treatment or a change to a different way of managing the condition of the ulcer. Some examples are detailed below; this is not an extensive list, but aims to provide examples for consideration.

Diagnostic methods

      There are more advanced methods to assess PAD, such as magnetic resource angiograms or computer tomography angiograms, which may be performed by a vascular specialist, if required.

      Early detection of sub-epidermal moisture (SEM) changes can be measured using the electrical properties of skin (bioimpedance).101–102 A recent literature review concluded that the SEM scanner (Bruin Biometrics) is an objective and reliable method of local bioimpedance, and therefore, enables assessment of tissue damage before there are visible signs of it present.102

      Advances in detection of bacteria in wounds have been made and a handheld fluorescence imaging device (Moleculight i:X; distributed by Smith & Nephew) has been made available. Moleculight uses safe 405nm light to visualise bacteria by detecting porphyrins that fluoresce red146 and pyoverdine/ siderophores produced by Pseudomonas aeruginosa that fluoresce cyan. Moleculight helps the practitioner visualise where bacteria are located in the wound to target and monitor debridement effectively,147 providing information as to a clinically relevant level of biobuden (>104 colony forming units/g).

      Point of care swab tests may also aid the assessment of whether wounds are non-healing due to elevated host protease activity or bacterial pathogenesis. Woundchek Bacterial Status detects bacterial protease activity, a common virulence factor that is indicative of pathogenic behaviour of bacteria in the wound before clinically observable infection, at a point in the infection continuum where antimicrobial treatment is typically required. Woundchek Protease Status detects elevated host protease activity (MMPs and neutrophil elastase), a marker of chronic wound inflammation.

      Preliminary data have suggested that an hyperspectral imaging system (TI-CAM, Diaspective Vision) may be useful as a diagnostic tool to help aid health professionals decide on treatment options by providing rapid tissue perfusion measurements, including superficial oxygenation (StO2 [%]), Tissue Haemoglobin Index, NIR Perfusion Index and Tissue Water Index in the wound.148 By combining the various pieces of information, it maybe possible to get a holistic picture of the condition of a wound.

Offloading

      In most cases, offloading can be achieved with low technology and relatively low-cost products. Where offloading is not successful, perhaps because the patient removes it or a previous amputation that has made it difficult to effectively offload the foot, the use of non-removable offloading or complete offloading using crutches or a wheelchair may be appropriate.

Debridement

      Debridement may need to be more aggressive to remove devitalised tissue. Where access to the operating theatre is possible, this is often achieved by surgical debridement. Other less aggressive debridement methods may be effective at removing biofilm without causing discomfort to the sensate patient. This in itself may enable better debridement, because the patient is able to tolerate the procedure better. An example is monofilament debridement pads.149 An alternative to sharp surgical debridement is hydrosurgery—using a pressurised water jet to remove devitalised tissue.150 This method may cause less pain and discomfort to the patient and be more suitable for patients who cannot tolerate surgery. Ultrasonic debridement should be considered, especially in DFU with grade of ischaemia when surgical debridement is contraindicated. Another example for wound cleansing is VAC Veraflo cleanse choice dressing (KCI), used with VAC Veraflo therapy, to initiate immediate wound cleansing and it may be considered when surgical debridement is not appropriate.

Managing infection

     The cornerstones of managing infection remain wound cleansing, debridement and antimicrobial agents. More aggressive debridement may be required to ensure that all reservoirs of infection and sites of potential re-infection have been removed. Once achieved, a change to a different topical antiseptic may be appropriate, in combination with systemic antibiotic therapy. Prophylactic antibiotics are not appropriate for all patients, but where the risk justifies it, then prophylaxis may be required.

Bioburden and biofilm

      Options for management of bioburden and biofilm include products containing cadexomer/provodine iodine (Iodosorb, Inadine), topical antimicrobials that also assists in desloughing. An alternative to the microbicidal activity of iodine is physical removal of organisms. An example is bacterial binding dressings (Cutimed Sorbact, BSN medical) that facilitate the passive hydrophobic binding of organisms, which become trapped in the dressing and are removed at dressing change.151 Advantages of this sort of therapy include lack of bacterial resistance, its ability to attract antibiotic-resistant bacteria, non-allergenicity and no cytotoxicity. In addition, as organisms are removed rather than killed, endotoxins are not released into the wound.

Exudate management

      Where exudation from the wound is high, options include highly absorbent dressings and NPWT. Highly absorbent dressings are able to absorb and retain large amounts of exudate, removing it from the wound and keeping it isolated from the skin. Examples include Cutimed Sorbion (BSN medical), Tielle Liqualock (KCI). Where the amount of exudate is too great for dressings, NPWT is a long-established alternative. Examples include Renasys Touch (Smith & Nephew) and VAC Therapy (KCI).

Healing enhances

      Outside of the normal therapies that are known to aid wound healing, there are adjunct therapies which do not fit in to the areas described.

      In recent years, topically applicable adjunctive therapeutic options have been developed in this area of wound care and a number of consensus documents support the use of oxygen as in chronic non-healing wounds. All approaches aim to deliver oxygen locally to increase the oxygen concentration in a specific area where it is most needed at a particular time. It is known that wound healing has a high oxygen demand. In many cases, DFUs and PUs are hypoxic, which requires additional oxygen supply. One such product is Granulox (Sastomed), which enhances the oxygen diffusion by using purified haemoglobin. Based on the available clinical evidence (Grade 1B),152 it has successfully been implemented in treatment regimens of PU and DFU.

      Other local oxygen therapies deliver an oxygen-rich atmosphere to the wound area, either by topical continuous delivery of non-pressurised (normobaric) oxygen (CDO) through small cannulas or thin tubes (Natrox/Epiflo) to wound dressings, or by small chamber based constant pressure devices (TWO2 /TO2 ).118,152

      There are also a number of healing enhancers which affect the mediators of inflammation, such as MMPs and elastase (collagen/ORC (Promogran, KCI). A systematic review of collagen wound dressings used in treatment of DFUs demonstrated that they can be effective in aiding healing.135

      Another healing enhancer, NOSF (sucrose octasulfate, Urgo Start), which inhibits MMPs as well as effecting neovascularisation, reported positive outcomes in a recent double-blind RCT.134 The results showed an increased healing rate and significant decrease of time to closure.

      Growth factors (GFs) and tissue equivalent (TE) products are available in some countries. GFs include becaplermin (e.g. Regranex; Smith & Nephew). TE products for which a range of cellular or acellular extracellular matrix-based sheets are commercialised (e.g. amniotic membrane allografts, foreskin-derived bioengineered grafts, split thickness skin grafts), including Omnigraft (Integra), which decreased the time to complete wound closure and increased the rate of wound closure in a recent clinical trial.153 Many authorities do not recommend growth factors and TE. These products are reimbursed by CMS in the US once the 4-week clinical response threshold has been reached.

      Advanced treatment modalities that are cost-effective and time-sensitive are often indicated for chronic nonhealing wounds to facilitate wound closure. Recent advances in wound care technologies, especially the advent of bioengineered alternative tissue, have provided numerous options to help with wound closure.

Summary

      Not every country has access to all these products. Where products are available, the diagnosis may govern which are covered by reimbursement or insurance. An example is the US, where a diagnosis of diabetes leads to access to advanced products and more highly-skilled practitioners. Furthermore, treatment modalities vary across the world, depending on local guidelines and professional groups that manage the wound. This document hopes to create some equity on how patients are managed, to provide information that enables adoption of best practices, and, where needed, to stimulate development of standards of care and education.

Education

Key points

● Education is the first step in ulcer prevention

● Health professionals should recognise the problem, know what to do, or who to refer the patient to

● Health professional education must be informed and supported by evidence-based guidelines on best practice

      Wound management grows ever more sophisticated, as our understanding of the fundamentals of wound formation, management and prevention increases. Standards of care advance; products, technologies and processes that improve care and outcomes are developed and launched. Education, for health professionals and patients, is vital. Education is the first step in ulcer prevention and management.

      Education is a long-term commitment for the learner and the educator, requiring messages to be repeated consistently over time in different formats. People learn in different ways, which the educator must acknowledge, and they must offer content that fits different learning styles. Furthermore, they must understand that the ability of the learner to see/hear the message, assimilate and reduce it to practice, varies by individual. Educational materials must account for these differences, understanding that many patients and family members may have basic educational attainment and poor language skills. Many patients, and indeed practitioners,154 already have long-standing and firmly-held beliefs about the condition, gleaned from sources which do not accord with medical opinion. For many, perhaps most patients, medical language is impenetrable.

This consensus focuses on three areas for education:

● Empower patients, families and carers

● The health system

● Social welfare.

A useful mnemonic for education is EDUCATION defined as follows:

E: Empower

D: Develop/deserve what they need

U: Understand problems/risks

C: Care

A: Advocate

T: Teach

I: Inquire

O: Observe

N: Nurture.

      Empower patients, families and carers The patient’s socioeconomic status should be acknowledged, with the aim of maximising the role of the patient in reaching outcomes. Key areas are: understanding the condition; the implications and how they may affect the patient; risk categories; understanding glycaemia and managing it well in diabetes; how to prevent a wound forming; the role of foot protection by offloading and the importance of adherence; and daily foot care inspection and monitoring; what to do if problems arise with the foot and how to contact the right practitioner; what to do once the wound has formed (how to dress it, how to bathe with it); increase the level of knowledge about therapies, treatments, prevention of complications and prognosis; understand the patient’s, family’s and carer’s role in managing the wound and adhering to the care plan; how to help and encourage the patient; and how to explain to others about their condition. The patient should also be able to help the practitioner during consultations.  Preliminary evidence from Malaysia suggests patient education is successful in facilitating prevention and healing.155

Delivery

      Delivery can take a number of forms: clinic leaflets, posters, group sessions, face-to-face by the practitioner, pharmacists (when patients collect prescriptions), and websites. Facebook and social media can be a problem, with fake items and ‘crystal waving’—trying to heal people by the use of precious stones.100

The health system

      Consistent delivery of care across the health-care system depends first and foremost on educating the health professionals in best practices, which are underpinned by effective products, technologies and organisational support. However, consistent understanding of standards of care does not always exi. 156 The current baseline understanding of managing PU and DFU should be established. Health professionals should recognise the problem, know what to do and know how to operate within the health service. They must understand how best to educate their patients. Where gaps are identified, education should be provided and regularly updated. Health professional education must be informed and supported by guidelines on best practice developed in many countries and through a number of specialist national and international professional organisations. Where these guidelines are not already adopted, or require updating, health professionals should introduce relevant guidelines and education. The focus in many health systems is management of existing ulcers; a shift to prevention, supported by education of both patients and health professionals, would benefit patients, health professionals, and health-care systems and, importantly, be cost-effective.157

      The UK National Minimal Skills Framework158 covers health professional competencies required to manage foot diseases associated with diabetes. This is a good starting point for the basic competencies for DFU, including identifying risk status, basic foot care and advice, and managing a newly-presenting ulcer. It further details the higher level skill sets required for assessment of PAD, neuropathy, specialist education, advice on footwear, arranging surveillance based on risk status, tissue imaging management of Charcot foot and other skills.

      NICE in the UK has also proposed a list of practitioner education topics for PU prevention.107 Education includes: identifying patients at risk, recognising pressure damage, prevention, referral, conducting a risk assessment, repositioning, pressure redistribution devices, how to discuss prevention with patients and carers, and sources of help and advice.

      A comprehensive set of topics for patient education that the practitioner should be able to communicate to a patient with diabetes at risk of foot disease, and which the patient should expect to be told, is proposed by the Saskatchewan Ministry of Health in Canada.111 The list, a good template for patient focused education on self-management, suggests:

● Self-care and monitoring of diabetes

● The potential impact of diabetes on the feet

● Daily examination of feet and knowing when to seek advice from a health professional. Indicators include: any colour change; swelling; breaks in the skin; pain or numbness; alerting professionals, if self-care and monitoring is not possible or difficult

● Implications of loss of protective sensation

● Possible consequences of neglecting the feet

● Methods to help self-examination/monitoring, for example, the use of mirrors, if mobility is limited

● Hygiene (daily washing and careful drying)

● Skin care (moisturiser use)

● Nail care

● Dangers associated with inappropriate mechanical and chemical skin removal

● Footwear (the importance of well-fitting shoes and hosiery)

● Injury prevention and the importance of not walking barefoot when reduced sensation is present

● Annual foot examination by trained professional, to assess for neuropathy and vascular disease

● Prompt detection and management of any problems are important, and seeking help as soon as possible.

Societal

      The general public tends to have at best incomplete knowledge of medical matters, and at worst ‘knowledge’ gleaned from unreliable sources. The current media attention focused on multiple drug resistant organisms is an example of how this can be addressed, although compelling evidence showing wider understanding and behaviour change is yet to be seen. October is Breast Cancer Awareness month and this is widely known—for a disease that is known by all and feared in equal measure and for which people are motivated and mobilised to raise funds through charity events. However, few people know that September is PAD Awareness month (It is also worth noting and publicising international days such as Stop the Pressure—15 November 2018 and World Diabetes Day—14 November 2018). These messages show how societal education perhaps should be tackled. The messages should raise awareness, understanding and societal support for patients suffering from non-healing wounds. The public should be made aware not only of the causes of PUs and DFUs and how their choices affect the causes, but also the impact non-healing wounds have on QoL, and life itself. A DFU, for example, is associated with increased risk of mortality.159 Vehicles for achieving greater awareness are NGOs, religious organisations, the media. The impact that chronic wounds have in the UK was discussed in Parliament in 2017. The awareness that triggered the debate was raised by publications demonstrating the financial and organisational impact of non-healing wounds. Perhaps this is a model for the future.

Future research

Key points

● A number of gaps were identified by the expert panel convened to develop this document

● Nutrition is a key component in standards of care for chronic wounds, but little is understood for DFU

● This document should be regarded as a working document aimed to help health professionals make sense of a very challenging area.

      Development of consensus guidelines for chronic wounds is based on available information on the underlying disease, the pathophysiology of ulceration and tissue breakdown, the influence of pathophysiology on recalcitrance, conversion of a chronic non-healing ulcer into a healing wound that will close and remain closed, the causes of recurrence, the influence of individual treatments, the efficacy of standards of care, and nutrition. Consensus opinions consider the quality of available data by examining the methodological strength of published studies, as well as consideration of real-world expert opinion based on experience. In so doing, gaps are identified in the evidence base, which are filled initially by expert opinion, but should be strengthened by methodologically sound studies. A number of gaps were identified by the expert panel convened to develop this document.

      A considerable body of evidence has been amassed to show how chronic wounds form and this is largely understood at the tissue level for PU and DFU.130,160–166 The role of PAD is also largely understood. The changes in skin due to diabetes before and after ulceration are described,167 the impact of advanced glycation end products on inflammation has been described168 and a possible role for Staphylococcus aureus has been identified.169 Some genetic associations are becoming clearer.170 A clearer understanding of the physiology of PU and DFU at the cellular level may help develop products targeted more effectively at the pathophysiology of these ulcers.

Nutrition in DFU: nutrition is a key component in standards of care for chronic wounds, but little is understood for DFU. The diabetic patient has metabolic challenges with glycaemic control and the full impact of the changes that happen in tissues of patients with diabetes that affect healing may not yet be fully elucidated.

      Evidence to support advanced modalities for PU. Many wound-management technologies have not  been subjected to rigorous high-quality randomised clinical trials (RCT). Where trials and evaluations have been conducted, often they are methodologically poor. When data from these studies are analysed using health technology assessment methodology, they are often found wanting, leaving interpretation of the clinical efficacy equivocal and supported by expert opinion. Patient care would be well-served by advanced technologies, with claims for effectiveness supported by high-quality, methodologically and statistically rigorous evidence.

      This is a consensus document developed by an expert panel. The panel reached a consensus on differentiating between PU and DFU on the heel in particular. In so doing, it arrived at a series of recommendations that would ideally be implemented. However, the panel recognised that the recommendations in their entirety may not fit every health-care system, for a variety of reasons discussed in the document. These recommendations should therefore be used in line with local/national guidelines that are relevant to the reader’s own country/area. This should be regarded as a working document aimed to help health professionals make sense of a very challenging area.

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This article is excerpted from the JOURNAL OF WOUND CARE n SUPPLEMENT C ONSENSUS DOCUMENT VOL 27, NO 5, MAY, 2018 by Wound World.