A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Applied Biologics, LLC
Summary
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Description
This study follows a rescue design: patients in the SOC arm who fail to heal during the CAMPX Prospective Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive the study product. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process. * The poten…
Interventions
- OtherXWRAP
Application of XWRAP + standard of care for up to 12 weeks.
Location
- Royal ResearchHollywood, Florida