AXOLCAMP: A Multicenter, Prospective Randomized Controlled Trial Of Dehydrated Human Amnion Membrane Plus Standard Of Care Versus Standard Of Care Alone For Nonhealing Diabetic Foot Ulcers: Mid-Study Analysis

Background: Diabetic foot ulcers (DFUs) remain difficult to heal despite comprehensive standard care, and advanced wound-care strategies are frequently evaluated as adjuncts when wounds fail to progress. AXOLCAMP is an ongoing multicenter, open-label, randomized controlled trial evaluating a product specific dehydrated human amnion membrane (dhAM), Axolotl DualGraft™, plus standard of care (SOC) versus SOC alone in nonhealing DFUs. Methods: Adults with type 1 or type 2 diabetes and an eligible nonhealing DFU are randomized to dhAM plus SOC or SOC alone. The protocol targets 100 evaluable participants (50 per group), with recruitment of approximately 112–115 participants to account for anticipated attrition. The primary endpoint is the proportion of target ulcers achieving complete wound closure within 12 weeks. Secondary endpoints include time to closure, percent area reduction (PAR), adverse events, pain, and wound-related quality of life. This manuscript reports a mid-study analysis, using data provided on 23 September 2026. These data sets do not include the complete randomized schedule which has yet to be fully enrolled as the study is still ongoing. Results: At the supplied operational snapshot, 171 participants had been screened, 86 had been randomized, 46 had completed the study, and 25 remained ongoing. Apparent complete 12-week wound closure from completed subjects (protocol modification without confirmation) for the SOC and SOC + Treatment groups was observed in 3/19 (15.8%) and 5/27 (18.5%), respectively. Mean PAR at 12 weeks was 19.16% versus 41.07%, respectively. Safety outcomes were similar across both groups (SOC = 31.8%, SOC + Treatment = 33.3%). Pain, Enjoyment of Life, and General Activity (PEG) scores at week 12 were significantly lower in the dhAM + SOC group than in the SOC-alone group (1.31± 2.11 vs. 2.86 ± 2.97; p = 0.044). Between-group change from baseline did not differ (p = 0.774) Conclusions: This mid-study analysis provides an early randomized comparison of dhAM plus SOC versus SOC alone in nonhealing DFUs. Preliminary findings suggest an increase in PAR with adjunctive dhAM, while its effect on complete wound closure remains uncertain. Because enrollment and follow-up remain ongoing, these findings should be interpreted as exploratory and do not replace the prespecified final analysis of the completed trial. Keywords: CAMPs; diabetic foot ulcer; dehydrated human amnion membrane; amniotic membrane; randomized controlled trial; wound closure; percent area reduction; standard of care; AXOLCAMP