A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone
Skye Biologics Holdings, LLC
Summary
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (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) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection
Description
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of diabetic foot ulcers (DFUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement. 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…
Interventions
- OtherE-GRAFT ™
E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue-Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act.
- DeviceFIBRACOL™
510K FDA cleared Collagen alginate dressing
Location
- Professional Education and Research InstituteRoanoke, Virginia