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Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 provide informed consent or obtain consent from legal authorized representative (LAR) Exclusion Criteria: 1. Subject is pregnant 2. Subject with diagnosed diabetes has HbA1C \> 12 within 3 months Prior to randomization 3. Subject has \> 30% reduction in wound size after 2-week run-in period 4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria 5. Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI 6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \< 10 mg per day of prednisone 7. Subject is currently undergoing cancer treatment 8. Subject has used biologic skin substitutes within 14 days of enrollment 9. Subject has an allergy to suture material 10. Subject has life expectancy less than six-months as assessed by the investigator 11. Subject is participating in another clinical research study prior to this study completion
About the study
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.
What is being tested
- PelloGraft (other)
- SanoGraft (other)
Sponsor: Surgenex · Participants: 180 · Started: Jun 23, 2024
Contact the study team
- Pam McKeown · Phone: 480-404-3143
Official record on ClinicalTrials.gov — NCT06515093
Locations in the U.S.
| California | ILD Research, Vista |
| Oklahoma | Tulsa Wound Center, Tulsa |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.