Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial
Summary: This prospective multicentre RCT (n=218, complex DFUs extending to dermis/bone) compared dehydrated amnion chorion membrane (dACM) + standard of care (SOC) vs SOC alone over 12 weeks. dACM + SOC achieved 50% complete wound closure (CWC) vs 35% for SOC (p=0.04), with median time to CWC 84 days (not achieved for SOC, p=0.04). Hazard ratio 1.48 (95% CI 0.95-2.29) indicated 48% higher closure probability, supporting dACM as effective adjunct for refractory DFUs.
Key Highlights:
- Population: 109/group; Wagner grade 2-4; mean duration 4 months, area 3.5 cm².
- Outcomes: Week 12 CWC 50% vs 35%; weeks 4/6/8/10: 12%/22%/31%/42% vs 8%/11%/21%/27%.
- Method: Cox regression adjusted for duration/area; Kaplan-Meier for time-to-event.
- Safety: Similar AEs; dACM applied weekly post-debridement.
- Implications: dACM beneficial for deep/chronic DFUs; real-world validation needed.
Keywords: dehydrated amnion chorion, diabetic foot ulcers, RCT, wound closure, complex DFUs