Foot ulcer treatment with the PulseFlowDF Boot

INTERVENTION: All the participants will be asked to participate in the study for 3 months during which they will be asked to use the allocated treatment for 3 months. Random allocation of participants to each treatment arm will be assigned using a random numbers table. The order of allocation in each group will follow even and odd numbers as they appear in the table to ensure unbiased allocation. Concealment of the randomisation will be maintained by sealed opaque envelopes; these will be produced by the blinded research assistant for each participant. Intervention treatment: PulseFlowDF is a non‐invasive treatment for diabetic foot ulcers that has a novel technology which attempts to address the complexity of ulcer healing through increased blood flow, pressure reduction and maximisation of compliance. In several clinical trials it has also been shown that total contact casting can improve healing in neuropathic foot ulcerations. For those that have circulation (vascular) impairment this approach is limited and orthotic devices (walkers) are not always used constantly. Currently, there is no technology that attempts to resolve this. In addition, PulseFlowDF solves the step‐down issue, as the boot can be used as a shoe, saving the clinical departments further costs for footwear to potentially prevent ulcer re‐occurrence. Comparator treatment: We propose to use a below knee Aircast Air Select Standard boot as it is a widely used orthotic device that can immobilise the leg and foot. This boot is widely available on the NHS and is used in pressure reduction for people with foot ulcers. CONDITION: Diabetes mellitus ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: Foot ulcer size, measured at baseline, 4, 8 and 12 weeks SECONDARY OUTCOME: 1. Health status, measured with the EQ‐5D questionnaire at baseline and 12 weeks; 2. Walking impairment, measured with the Walking Impairment Questionnaire at baseline and 12 weeks; 3. Thermal image analysis at baseline, 4, 8 and 12 weeks; 4. Foot pressure, measured using Tekscan in‐shoe plantar pressure measurement at baseline and 3 months ; 5. Adherence to boots assessed at 4, 8 and 12 weeks INCLUSION CRITERIA: 1. >17 years of age 2. Consultant or GP diagnosis of diabetes mellitus (type I or II) documented on the electronic patient record with HbA1C greater than 48mmol/mol recorded in the last 6 months 3. Controlled diabetes as defined as an HbA1c of 86mm/mol (11%) in the last 3 months 4. Foot ulcers (defined by the University Texas wound Classification grades 1A, 1B, 1C, 2A, 2B, 2C) and greater than the volume of 30mm3 (as determined by 3D camera) and or minimum length and width of 5mm x 5mm and 2mm depth 5. Foot ulcer (as defined above) with or without mild infection as defined by IDSA as local infection involving only the skin and the subcutaneous tissue (without involvement of deeper tissues and without systemic signs as described below). If erythema, must be >0.5 cm to = 2cm around the ulcer, once all other causes of an inflammatory response of the skin (e.g. trauma, gout, acute Charcot neuro‐osteoarthropathy, fracture, thrombosis and venous stasis) are e