Effectiveness of offloading interventions for people with diabetes-related foot ulcers: A systematic review and meta-analysis.

BACKGROUND: Offloading treatment is crucial to heal diabetes-related foot ulcers (DFU). This systematic review aimed to assess the effectiveness of offloading interventions for people with DFU. METHODS: We searched PubMed, EMBASE, Cochrane databases, and trials registries for all studies relating to offloading interventions in people with DFU to address 14 clinical question comparisons. Outcomes included ulcers healed, plantar pressure, weight-bearing activity, adherence, new lesions, falls, infections, amputations, quality of life, costs, cost-effectiveness, balance, and sustained healing. Included controlled studies were independently assessed for risk of bias and had key data extracted. Meta-analyses were performed when outcome data from studies could be pooled. Evidence statements were developed using the GRADE approach when outcome data existed. RESULTS: From 19,923 studies screened, 194 eligible studies were identified (47 controlled, 147 non-controlled), 35 meta-analyses performed, and 128 evidence statements developed. We found non-removable offloading devices likely increase ulcers healed compared to removable offloading devices (risk ratio [RR] 1.24, 95% CI 1.09-1.41; N = 14, n = 1083), and may increase adherence, cost-effectiveness and decrease infections, but may increase new lesions. Removable knee-high offloading devices may make little difference to ulcers healed compared to removable ankle-high offloading devices (RR 1.00, 0.86-1.16; N = 6, n = 439), but may decrease plantar pressure and adherence. Any offloading device may increase ulcers healed (RR 1.39, 0.89-2.18; N = 5, n = 235) and cost-effectiveness compared to therapeutic footwear and may decrease plantar pressure and infections. Digital flexor tenotomies with offloading devices likely increase ulcers healed (RR 2.43, 1.05-5.59; N = 1, n = 16) and sustained healing compared to devices alone, and may decrease plantar pressure and infections, but may increase new transfer lesions. Achilles tendon lengthening with offloading devices likely increase ulcers healed (RR 1.10, 0.97-1.27; N = 1, n = 64) and sustained healing compared to devices alone, but likely increase new heel ulcers. CONCLUSIONS: Non-removable offloading devices are likely superior to all other offloading interventions to heal most plantar DFU. Digital flexor tenotomies and Achilles tendon lengthening in combination with offloading devices are likely superior for some specific plantar DFU locations. Otherwise, any offloading device is probably superior to therapeutic footwear and other non-surgical offloading interventions to heal most plantar DFU. However, all these interventions have low-to-moderate certainty of evidence supporting their outcomes and more high-quality trials are needed to improve our certainty for the effectiveness of most offloading interventions.

Guidelines for the management of diabetes in care homes during the Covid-19 pandemic.

The National Diabetes Stakeholders Covid-19 Response Group was formed in early April 2020 as a rapid action by the Joint British Diabetes Societies for Inpatient Care, Diabetes UK, the Association of British Clinical Diabetologists, and Diabetes Frail to address and support the special needs of residents with diabetes in UK care homes during Covid-19. It was obvious that the care home sector was becoming a second wave of Covid-19 infection and that those with diabetes residing in care homes were at increased risk not only of susceptibility to infection but also to poorer outcomes. Its key purposes included minimising the morbidity and mortality associated with Covid-19 and assisting care staff to identify those residents with diabetes at highest risk of Covid-19 infection. The guidance was particularly created for care home managers, other care home staff, and specialist and non-specialist community nursing teams. The guidance covers the management of hyperglycaemia by discussion of various clinical scenarios that could arise, the management of hypoglycaemia, foot care and end of life care. In addition, it outlines the conditions where hospital admission is required. The guidance should be regarded as interim and will be updated as further medical and scientific evidence becomes available.

Indicators of prognosis for admissions from a specialist diabetic foot clinic: a retrospective service improvement exercise.

OBJECTIVE: To look at haematological and biochemical variables as predictors of outcomes in people admitted to hospital with a diabetic foot ulcer (DFU) without the use of technology or devices. In particular, to see if there was a relationship between admission blood cell and protein levels, and the likelihood of angioplasty, amputation, and death at one year after admission. METHOD: A five-year retrospective analysis of patients admitted to a tertiary multidisciplinary specialist diabetic foot clinic looking at admission C-reactive protein (CRP), white cell count (WCC), neutrophil count and HbA1c and their relationship to likelihood of angioplasty, minor or major amputation, and death at one year after admission. RESULTS: We identified 206 patients, in whom there was 1 year mortality rate of 6.3%. Raised WCC and CRP levels were significantly associated with major amputation (p=0.0035 and p<0.01, respectively). Raised WCC and neutrophil levels and were significantly associated with mortality (p=0.01 and p=0.002, respectively). The need for angioplasty was associated with raised CRP (p<0.05) but not with WCC or neutrophil count. There was no association of risk of minor amputations with admission HbA1c, CRP, WCC and neutrophils. Mean length of hospital stay was 17.5 (standard deviation ±14.0) days. CONCLUSION: Commonly measured haematological and biochemical markers were useful predictors of outcomes for patients admitted to hospital for acute foot wounds. In addition, we found a much lower 1 year mortality and shorter length of hospital stay than previously recorded, possibly due to the introduction of a multidisciplinary weekly ward round.

5 year retrospective follow-up of new cases of Charcot neuroarthropathy-A single centre experience.

BACKGROUND: Few data describe the natural history of Charcot neuroarthropathy treated with a total contact plaster cast (TCC). METHODS: A 5 year retrospective analysis of 50 patients presenting with an acute CN, Assessing time to clinical resolution into appropriate footwear and assessing if initial immobilisation device influenced resolution time. RESULTS: During the study period 42 patients (84%) of patients went into remission, 2 died during their treatment, 4 had major amputations, in 2 patients treatment was ongoing. 36 patients were treated with combination offloading devices, 6 were treated with one modality only. Median time to resolution for patients initially treated with a TCC was not significantly shorter than for those treated with a removable below knee boot. 34.9% required re-casting due to clinical deterioration in the removable device. CONCLUSIONS: More precise measures of resolution of CN are needed to assess the impact of initial treatment modality on time to resolution.

An open, non-comparative, multicentre evaluation of performance and safety using an antimicrobial exudate transfer dressing on diabetic foot ulcers: a case series.

OBJECTIVE: To evaluate the performance and safety of Mepilex Transfer Ag (MTAg) in the treatment of infected diabetic foot ulcers (DFU). METHOD: Patients with locally infected DFU were treated with the test dressing for up to 4 weeks, with a further 12 weeks of follow-up in a non-comparative study. Changes to wound infection and wound size as well as the condition of the peri-wound skin from baseline were assessed. Wound pain during dressing change was measured using a visual analogue scale (VAS). The investigators and patients documented their opinions on their overall experience of the test dressing and on key performance parameters. RESULTS: Following treatment with the test dressing, the signs and symptoms of local wound infection present in the target DFU were substantially reduced compared with baseline. Following the posttreatment evaluation, the majority of the DFU exhibited no signs of infection. and mean wound size was reduced by 50%. Wound size also continued to steadily decrease during follow-up. At the end of treatment five DFUs were completely healed and a further six healed by the end of the follow-up period. Concomitantly, over the course of the study, wound exudate levels were reduced and there was a significant improvement in the condition of the peri-wound area. Wound pain at dressing change was low throughout; generally patients felt no anxiety during the dressing change procedure. The patients considered it a comfortable dressing that remained in place and allowed ease of movement during wear. The investigating clinicians were highly satisfied with the overall performance, especially with respect to its ease of application and removal, conformability and flexibility. CONCLUSION: This study has demonstrated the potential of the dressing to provide topical antimicrobial activity directly to an infected DFU, suggesting prompt treatment of an infected DFU with this topical antimicrobial could aid wound complications. DECLARATION OF INTEREST: The authors have no conflict of interest to declare.

Factors determining the risk of diabetes foot amputations--A retrospective analysis of a tertiary diabetes foot care service.

AIMS: To identify which factors predict the need for minor or major amputation in patients attending a multidisciplinary diabetic foot clinic (DFC). METHODS: A retrospective analysis of patients who attended over a 27 month period were included. Patients had to have attended ≥3 consecutive consultant led clinic appointments within 6 months. Data was collected on HbA1c, clinic attendance, blood pressure, peripheral arterial disease (PAD), and co-morbidities. Patients were followed up for 1 year. RESULTS: 165 patients met the inclusion criteria. 121 were male. 33 patients had amputations. There was an association between poor glycaemic control at baseline and risk of amputation when adjusted for other factors, with those patients having HbA1c ≤58mmol/mol (7.5%) at less risk of amputation with an odds of 0.14 (0.04-0.53) of amputation(p=0.0036). Other statistically significant factors predictive of amputation were: missing clinic appointments (p=0.0079); a high Charlson index (p=0.03314); hypertension (p=0.0216). No previous revascularisation was protective against amputation (p=0.0035). However PAD was not seen to be statistically significant, although our results indicated a lower risk of amputation with no PAD. Overall, 34.9% (n=58) of patients had good glycaemic control (HbA1c <58mmol/mol, [7.5%]) at baseline and 81.3% (n=135) had improved their glycaemic control at their last follow up appointment. CONCLUSIONS: In this cohort poor glycaemic control, poor attendance, previous revascularisation and hypertension were associated with higher risk of amputation, with PAD showing a trend. Moreover, we demonstrated benefits in glycaemic control achieved by attending this DFC, which is likely to translate to longer term diabetes related health benefits.

An antibiotic formulary for a tertiary care foot clinic: admission avoidance using intramuscular antibiotics for borderline foot infections in people with diabetes.

AIMS: To develop an antibiotic foot formulary for the empirical treatment of diabetes-related foot infections presenting to our service. Subsequently, to asses costs associated with the introduction of our protocol, in particular to assess the effect on admissions avoidance and any cost savings achieved. METHODS: We reviewed several existing antibiotic protocols. We analysed data on costs related to treatment and admission rates prior to and after the introduction of the protocol. RESULTS: We rationalized our antibiotic protocol and adapted the Infectious Disease Society of America guideline by introducing a category of 'moderate infection-borderline admission' to our classification. This enabled the administration of outpatient intramuscular antibiotics. After introducing the rationalized protocol, our average antibiotic prescribing costs for a 3-week course of treatment fell from £17.12 to £16.42. Over 22 months of follow-up, 26 episodes were eligible for treatment with intramuscular antibiotics. Over the same time period, 121 people were admitted directly from the foot clinic. The costs saved as a result of avoided or delayed admission for those 26 episodes was over £76 000. For 12 people who required subsequent admission, their length of hospital stay was significantly shorter than those admitted directly [9.25 days (range 2-25) vs. 16.11 (2-64), P = 0.045]. CONCLUSIONS: By modifying the Infectious Disease Society of America classification and adopting a protocol to administer outpatient oral and intramuscular antibiotics, we have led to substantial cost savings, shorter hospital admissions and also have developed a successful admissions avoidance strategy.

Clinical experience of a new NPWT system in diabetic foot ulcers and post-amputation wounds.

OBJECTIVE: The primary aim of this pilot observational study was to assess the reduction in wound depth and area achieved with a new negative pressure wound therapy (NPWT) system in diabetic patients with foot ulcers and post-amputation wounds. Secondary aims were to assess pain levels, extent of exudate removal, and ease of use of the system for both the patient and care giver. METHOD: Patients in both acute and home care settings were enrolled into this 4-week study. Dressings were changed three times per week. Wound area and depth, exudate removal and pain severity were evaluated at each dressing change. At the final visit, the investigators and patients were surveyed with respect to equipment and dressings used in the study. RESULTS: Sixteen patients were enrolled into the study. Data relating to 14 patients with a variety of post-amputation wounds were included in the intention-to-treat (ITT) analysis. The post-amputation wounds showed a general trend for a reduction in the median wound surface area between baseline (22.9cm2; range 0.5-55) and the final visit (15.3cm2; range 2.4-63.5). This equates to a median change (calculated from the percentage change in wound area for each patient individually) of -41% (range -82% to +15%). There was also a general trend in reduction in the median depth between baseline (17mm; range 0-35) to final visit (5mm; range 0-35). One patient presented with a foot ulcer that demonstrated a 50% reduction in depth from baseline to the final assessment. The device effectively managed wound exudate and most patients reported low pain levels during therapy. Ease of use of the system was rated very highly by investigators and patients. CONCLUSION: This pilot study indicates that the use of the new NPWT system can be expected to have a positive effect on the healing of post-amputation wounds and foot ulcers in patients with diabetes. The findings demonstrate that the system is easy to use, effectively controls exudate and minimises pain and inconvenience for patients being treated with NPWT. DECLARATION OF INTEREST: This study was sponsored by Mölnlycke Heath Care (Gothenburg, Sweden) and Medela AG (Baar, Switzerland). The authors have no other conflicts of interest that are directly relevant to the content of this manuscript.

A holistic approach to the management of a neuropathic plantar ulcer.

While pressure relief is a vital component of the treatment of neuropathic plantar foot ulcers, many patients are reluctant to wear offloading devices. Healing is more likely to occur if the patient is happy with its appearance and comfort.