Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled...

Area of Science:

• Podiatry
• Wound Healing
• Clinical Trials

Background:

• Diabetic foot ulcers (DFU) affect over 425 million people globally, with a 25% lifetime risk.
• Current DFU management includes debridement, dressings, offloading, infection/ischaemia treatment, and glycaemic control.
• Advanced adjuvant therapies for DFU are limited by cost and evidence.

Purpose of the Study:

• To evaluate the efficacy of hydrosurgical debridement with or without decellularised dermal allograft and negative pressure wound therapy as adjuncts to standard care for hard-to-heal DFUs.
• To determine if an effective treatment strategy reduces time to ulcer healing compared to standard care alone.
• To assess secondary outcomes including healing status, infection rates, reulceration, quality of life, and cost-effectiveness over 52 weeks.

Main Methods:

• A multicentre, seamless phase II/III, open-label, randomised controlled trial with blinded outcome assessment.
• Up to 447 participants with hard-to-heal DFUs will be randomised.
• Phase II will assess 50% ulcer area reduction at 4 weeks; Phase III will compare time to healing for selected strategies against standard care.

Main Results:

• Phase II primary endpoint: 50% reduction in index ulcer area at 4 weeks.
• Phase III primary endpoint: Time to healing of the index ulcer.
• Secondary endpoints: Healing status, infection, reulceration, quality of life, cost-effectiveness, and adverse events over 52 weeks.

Conclusions:

• The trial aims to identify advanced adjuvant therapies that are effective, safe, and cost-effective for managing hard-to-heal diabetic foot ulcers.
• Results will inform clinical practice and potentially reduce the burden of DFU on patients and healthcare systems.