Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC (NCT06515093)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: ILD Research — Vista, California
Age range: 18 Years
🧪 Interventions in This Study
- PelloGraft (OTHER)
- SanoGraft (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- ILD Research — Vista, California
- Tulsa Wound Center — Tulsa, Oklahoma
📞 Contact the Study Coordinator
Phone: (480) 404-3143
Email: pamela.mckeown@surgenex.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcer
- Omega3 Wound Fish Skin Graft in the Treatment of DFUs — Coconut Creek, Florida
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.