Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care V
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
| Condition(s) | Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Subjects must be at least 18 years of age or older, 2. Subjects must have a 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 cm2 and a maximum surface area of 20.0 cm2 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 Wager 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle, provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone. 7. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Applied Biologics, LLC |
| Locations | Clinton Township, Michigan, United States |
| Start date | 2024-09-20 |
| NCT ID | NCT06564831 |
| Official listing | https://clinicaltrials.gov/study/NCT06564831 |