A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers
MiMedx Group, Inc.
Summary
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Description
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers. The study will evaluate two products, EPIEFFECT® and EPIXPRESS™, which are both ppLHACMs.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 measured post debridement. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wagner 1 or 2 grade, extending at least through the…
Interventions
- OtherStandard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
- OtherEPIEFFECT
Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
- OtherEPIXPRESS
Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Location
- SerenaGroup - MonroevilleMonroeville, Pennsylvania