Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Chang
| Condition(s) | Venous Leg Ulcers |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Change in pain levels * Occurrence of infection |
| Who can participate | Inclusion Criteria: 1. Subjects must be at least 18 years of age or older. 2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure. 3. 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. 4. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. 5. The subject must consent to using the prescribed off-loading method for the duration of the study. 6. The subject must agree to attend the weekly study visits required by the protocol. 7. The subject mu |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Skye Biologics Holdings, LLC |
| Locations | Roanoke, Virginia, United States |
| Start date | 2024-12-28 |
| NCT ID | NCT06764953 |
| Official listing | https://clinicaltrials.gov/study/NCT06764953 |