Chronic, nonhealing diabetic foot ulcers (DFU) are increasing in prevalence and are often unresponsive to conventional therapy. Adipose tissue, containing adipose‐derived stem cells, and platelet rich plasma (PRP) are regenerative therapies rich in growth factors which may provide a solution to chronic wound healing. This study aimed to assess the feasibility of conducting a definitive randomised controlled trial (RCT) to investigate the efficacy of these therapies for the treatment of DFU. This was a single centre, feasibility, three‐arm, parallel group RCT. Eligible DFU patients were randomised on a 1:1:1 basis to three intervention arms: control (podiatry); fat grafting; fat grafting with PRP. The intervention was delivered once and patients were followed‐up for 12 weeks. The primary objective was to assess measures of trial feasibility. Clinical outcomes and health‐related quality of life (HRQoL) were also evaluated. Three hundred and thirty four patients were screened and 32 patients (9.6%) were deemed eligible with 18 enrolled in the trial (6 per arm) over 17 months. All participants completed the trial with no withdrawals or crossover. Participant engagement was high with most HRQoL questionnaires returned and only 4.8% follow‐up appointments missed. There were five adverse events (AEs) related to the trial with no serious AEs. Five (28%) of the wounds healed. There was no difference between any of the groups in terms of clinical outcomes. This feasibility study demonstrated that a multi‐centre RCT is safe and feasible with excellent patient engagement. We have highlighted crucial information regarding methodology and recruitment, which will guide future trial design. Registration number: NCT03085550 http://clinicaltrials.gov. Registered 01/03/2017.

Diabetic foot ulcers (DFUs) are common and disabling, giving rise to significant morbidity and mortality as well as worldwide socioeconomic problems. Despite treatment, DFUs readily become chronic wounds and may lead to major lower limb amputations. The pathogenesis of DFUs is complex and the main aetiologies are peripheral neuropathy, ischaemia from peripheral arterial disease and biomechanical abnormalities. Microvascular disease is also a significant problem for people with diabetes and contributes to foot ulceration. Successful management of DFUs consists of debridement, infection control, the use of offloading appliances and revascularisation where necessary. Foot ulcers are usually associated with infection and inflammation which lead to surrounding oedema of the foot. Standard offloading devices such as total contact casts and removable cast walkers do not actively reduce foot oedema. There is promising evidence that active oedema reduction by intermittent pneumatic compression in the diabetic foot improves ulcer healing. The objective of this article is to review the association of foot oedema and DFUs, including the role of appliances which reduce oedema. The information presented is vital to those involved in the management of DFUs.

IntroductionDiabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysisA multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.Ethics and disseminationEthics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.Trial registration numberISRCTN64926597; registered on 6 June 2017

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Foot and lower leg ulcers are particularly common in patients with diabetes. Current management strategies are often complex and time consuming for health care professionals and uncomfortable for the patient. A novel wound dressing device, the Kerraboot®, was assessed for its ease of use and patient acceptability in 14 patients with foot and lower leg ulcers. The dressing device was used for a period of up to 28 days, after which patients and health care professionals were asked to complete questionnaires. The results confirmed the comfort, utility, convenience and ease of application and removal of the Kerraboot® in the management of such ulcers. Copyright © 2004 John Wiley & Sons, Ltd.