Chronic Wound Care Management and Research
Interim analysis of single-layer amniotic membrane for the management of chronic diabetic foot ulcers in the CAMPX trial
By Thomas E Serena, Brianna Tramelli, Emily Cook and 3 others.
Abstract
Background
Diabetic foot ulcers (DFUs) remain one of the most persistent and debilitating complications associated with diabetes, resulting in significant adverse health outcomes, reduced quality of life, and substantial healthcare costs. Although treatment options have improved, many ulcers still do not fully close under the current standard of care (SOC). These challenges highlight the ongoing need for therapies that are both effective and economically sustainable.
Methods
This randomized controlled multicenter clinical trial assessed whether supplementing SOC with single-layer amniotic membrane (SLAM) improved healing outcomes compared with SOC alone in patients with chronic, non-healing DFUs. The primary outcome was complete ulcer closure over a 12-week treatment period. Wounds were considered closed when full re-epithelialization without drainage was observed at two consecutive weekly assessments (with a ±3-day window), verified by an independent, blinded review panel. Additional analyses included weekly evaluations of percent area reduction (PAR) from TV-1 to TV-13 using both digital planimetry and clinical examination.