Comparing Two Wound Care Devices to Standard Treatment for Hard-to-Heal Diabetic Foot and Venous Leg Ulcers

What this Trial Is About

Researchers are studying patients with hard-to-heal diabetic foot ulcers DFUs and venous leg ulcers VLUs to compare the effects of two wound care devices against standard care. This multicenter, randomized platform trial evaluates a saline-hydrated allogeneic dual-layer amniotic membrane product and a synthetic, resorbable polymeric wound matrix, with a matched retrospective control group from the US Wound Registry. The goal is to gather real-world evidence on treatment performance across diverse patient groups in everyday clinical settings. Participants are randomly assigned to receive one of the two investigational devices Membrane Wrap - Hydro, an amniotic membrane product derived from donated human birth tissue, or Microlyte, a synthetic absorbent polymeric wound matrix containing a small amount of silver to reduce microbial growth. All participants also receive standard care, which includes wound debridement, moisture balance, bacterial burden reduction, offloading, and compression. The control group consists of matched retrospective patients who received standard care alone. During the study, participants with nonhealing ulcers lasting more than four weeks are monitored for wound healing progress over 12 weeks. Assessments include wound size measurements and percent area reduction at weeks 4, 8, and 12. Researchers collect data on infections, amputations, hospitalizations, and patient-reported outcomes. The study aims to demonstrate the effectiveness of the devices in supporting complete wound closure compared to standard care, with safety and treatment outcomes tracked throughout the study period.

CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs