Dehydrated Amnion Chorion Membrane vs. Standard Care for Diabetic Foot Ulcers: RCT Results
Summary: This prospective, multicentre, randomised controlled trial evaluated dehydrated Amnion Chorion Membrane (dACM) plus standard of care (SoC) versus SoC alone in 218 patients with complex diabetic foot ulcers (DFUs) extending into dermis or deeper. Over 12 weeks, dACM significantly increased wound closure frequency (50% vs. 35% at week 12, p=0.04), with a 48% higher probability (HR 1.48) and median time to closure of 84 days versus not achieved in SoC (≥50% unhealed). Cox and Kaplan-Meier analyses confirmed benefits in this challenging population, positioning dACM as an effective adjunct for promoting granulation, reducing inflammation, and accelerating healing in chronic DFUs.
Key Highlights:
- At week 12, 50% of dACM-treated DFUs achieved complete wound closure (CWC) vs. 35% in SoC, with superiority from week 4 (12% vs. 8%).
- Hazard ratio of 1.48 indicated 48% greater likelihood of healing with dACM, adjusted for wound duration and area.
- Median time to CWC: 84 days for dACM vs. not achieved in SoC group (p=0.04 via Kaplan-Meier).
- Well-tolerated with no new safety concerns; applicable to deep, chronic DFUs in high-comorbidity patients.
- Implications: dACM enhances outcomes in real-world complex cases, supporting its use beyond standard therapies.
Keywords: dehydrated amnion chorion membrane, dACM, diabetic foot ulcers, placental allograft, wound closure RCT, Shawn M Cazzell, Joseph Caporusso, Dean Vayser