NCT07159282 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
| NCT ID | NCT07159282 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Applied Biologics, LLC |
| Condition | Diabetic Foot |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2027-08 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint. Exclusion Criteria: * The potential subject is known to have a life expectancy of \< 6 months. * The potential subject's target ulcer is not secondary to diabetes. * The target ulcer is infected or there is cellulitis in the surrounding skin. * The target ulcer expos