Trials / Recruiting
RecruitingNCT07159282
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Applied Biologics, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
- Diabetic Foot
- Foot Ulcer
- Ulcer Foot
- DFU
- Foot Ulcer Due to Type 2 Diabetes Mellitus
- Foot Ulcer Due to Type 1 Diabetes Mellitus
- Diabetic Foot Ulcer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | XWRAP | Application of XWRAP + standard of care for up to 12 weeks. |
Timeline
- Start date
- 2025-08-26
- Primary completion
- 2027-08-01
- Completion
- 2027-08-01
- First posted
- 2025-09-08
- Last updated
- 2026-02-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07159282. Inclusion in this directory is not an endorsement.