A clinical trial is testing whether combining multiple treatments—such as intensive debridement, negative pressure wound therapy, and a donor cell product—can heal diabetic foot ulcers faster than standard NHS care alone. Diabetic foot ulcers are slow-healing wounds that often lead to infection, amputation, and long hospital stays. Current treatment is inconsistent, and no single therapy works reliably for everyone. This trial systematically compares several combinations to find which ones actually improve healing. If the trial identifies effective combinations, the NHS could adopt a clear, evidence-based treatment pathway for diabetic foot ulcers. That would mean fewer amputations, shorter healing times, and lower healthcare costs—without requiring new drugs or expensive equipment. The results could also reshape how multidisciplinary foot clinics prioritise and sequence existing therapies. The trial is designed to feed directly into NHS practice, with cost-effectiveness analysis built in from the start. It does not explore fundamental biology; it tests practical, deliverable interventions that could be implemented immediately if proven effective.
View original technical description
DESIGN:Multi-centre, seamless Phase II/III, open, parallel group, multi-arm multi-stage RCT Randomisation: Via central 24hr automated service. Minimisation with random element in both Phases, stratified by centre, aetiology, ulcer duration, anatomical site & presentation Blinding: independent assessor to conduct outcome assessments; photography + digital planimetry of ulcer area; central blinded photography review of healing status SETTING: Multi-disciplinary DFU clinics TARGET POPULATION: Inclusion criteria: Aged>18; Diabetes Mellitus; chronic DFU or amputation; ulcer base not involving bone/joint; area>1cm2; ABPI>0.7; consent Exclusion criteria: Infection; HbA1C>110mmol/mol; eGFR>20mL/min/1.73m2; comorbidities affecting healing; planned revascularisation; previous growth factor treatment, revascularisation/foot surgery affecting healing >4 weeks; ulcer duration>2 years; expected non-compliance HEALTH TECHNOLOGIES: Phase II: 1.TAU control; 2.HD+TAU; 3.HD+7days NPWT+TAU; 4.HD+DCD+TAU; 5.HD+DCD+7days NPWT+TAU Phase III: TAU control; Up to 2 interventions from Phase II MEASUREMENT OF COSTS AND OUTCOMES: Phase II: Primary: >50% reduction in wound area at 4 weeks post randomisation Phase III: Primary: Time to healing of reference DFU Secondary: Proportion of DFU healed by 12/20/52 weeks; re-ulceration, infection, revascularisation, SAEs, amputation, admission to hospital and QoL (DFU-SF, EQ-5D-5L) at 4/12/20/52 weeks; health resource utilisation Follow-up visits at 2/4/12/20/52 weeks SAMPLE SIZE: Maximum of 660 patients recruited; 324 patients in Phase II; 336 patients in Phase III. Phase II: Effect size: absolute increase of 25% in the proportion of patients achieving 50% reduction in wound area by 4 weeks post randomisation (39% reach 50% reduction by week 4 in the TAU arm); 10% loss to follow-up Phase III: Effect size: hazard ratio of 1.5(median time to healing 21 weeks and 18% unhealed at 52 weeks with TAU); 2-sided 2% significance level (to control the family wise error rate at 5%), 10% loss to follow-up Overall power: ~83% and ~81% for recommending single & each of two effective interventions respectively ANALYSIS: Primary analyses on intention-to-treat patient population Phase II: Multivariable logistic regression fitted to achieving >50% reduction in wound area at 4 weeks with covariates for minimisation factors Phase III: Primary endpoint analysis: Cox Proportional Hazards regression model fitted to time to wound healing with covariates for minimisation factors and phase recruited. Deaths & amputations considered as competing risks; revascularisation considered as a time-dependent covariate Health Economics: cost of health & social care service utilization; incremental cost effectiveness ratios; within trial cost-effectiveness analysis CURRENT AND PLANNED CARE PATHWAYS: Care pathway for patients in both intervention and control arms of the trial will be the same and reflect NHS management responsibilities in MDT DFU clinics and community services. Patients will be screened, recruited and followed up during standard clinic visits. PROJECT TIMETABLES: Total 60 months (full trial): set-up 6 months, recruitment 22 & 12 months (Phase II & III respectively); follow-up 12 months; analysis 6 months. Recruitment rate:1-2 patients/month across 20 centres EXPERTISE IN TEAM: Multidisciplinary national team with clinical experts, methodologists (trialists, statisticians, health economist) & patient representative
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know