A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating Diabetic Foot Ulcers (DFU) and SanoGraft® in Treating Venous Leg Ulcers (VLU) to SOC Treatment
Surgenex
Summary
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is at least 18 years of age 2. Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes 3. Subject's wound is located on foot or ankle (DFU) or leg (VLU) 4. Subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2 5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg 6. Subject is willing and able to comply with all protocol requirements 7. Subject is willing and able to…
Interventions
- OtherPelloGraft
dual layer amnion/chorion-derived allograft
- OtherSanoGraft
single layer amnion-derived allograft
Locations (2)
- ILD ResearchVista, California
- Tulsa Wound CenterTulsa, Oklahoma