Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
Condition(s) studied
Investigational drug(s) / intervention(s)
PelloGraft: dual layer amnion/chorion-derived allograft
SanoGraft: single layer amnion-derived allograft
Study 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
Primary outcome measure(s)
- 100% epithelialization — 12 weeks (DFU) or 16 weeks (VLU)
100% epithelialization of wound within 12 weeks (DFU) or 16 weeks (VLU) of initial treatment application. Wound closure is complete with confirmation of 100% epithelialization, no drainage, and no need for additional dressings.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| ILD Research | Vista | California | Recruiting |
| Tulsa Wound Center | Tulsa | Oklahoma | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06515093 on ClinicalTrials.gov ↗ ← All trials in the USA