NCT06564831

Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Applied Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Detailed description

XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers \[13\]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane \[13\]. The product is screened and tested in a Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds AATB criteria \[13\].

Conditions

• Diabetic Foot Ulcer
• Diabetic Foot
• Foot Ulcer
• Ulcer Foot
• DFU

Interventions

Type	Name	Description
OTHER	SLAM + SOC	Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	SOC	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.

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2024-08-21
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States