Dehydrated Human Amnion Membrane Plus Standard Care in Non‑Healing Diabetic Foot Ulcers
A multicenter randomized controlled trial (AXOCAMP; NCT06550596), led by Axolotl Biologix and launched on September 23, 2024, is recruiting adults with non‑healing Wagner grade 1 or 2 diabetic foot ulcers (1–5 cm²) persisting for ≥4 weeks to evaluate whether adding a dehydrated human amnion membrane (dhAM; Axolotl DualGraft) to standard of care (SOC) accelerates healing compared to SOC alone. :contentReference[oaicite:0]{index=0}
Key Highlights:
- Population & Design: Up to 100 participants (age ≥18, Type 1 or 2 diabetes) with adequate limb perfusion (ABI 0.7–1.3, TBI ≥0.6, or TCOM ≥40 mmHg) and ulcer duration 4–52 weeks. Randomized parallel groups. :contentReference[oaicite:0]{index=0}
- Interventions: Experimental arm receives weekly Axolotl DualGraft (dhAM) applications plus SOC (offloading, debridement, moisture balance); control arm receives SOC alone. :contentReference[oaicite:0]{index=0}
- Endpoints & Monitoring: Primary endpoint is wound closure; assessments occur weekly. Eligibility excludes infected, osteomyelitic ulcers, immunosuppressed individuals, malnourished, pregnant, or severely comorbid patients. :contentReference[oaicite:0]{index=0}
- Timeline: Recruiting as of January 28, 2025; Target completion date: October 31, 2025. :contentReference[oaicite:0]{index=0}
Read the full trial registration on ClinicalTrials.gov.
Keywords:
dehydrated human amnion membrane,
diabetic foot ulcer,
standard of care,
Axolotl DualGraft,
clinical trial