NCT06515093

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Surgenex · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	PelloGraft	dual layer amnion/chorion-derived allograft
OTHER	SanoGraft	single layer amnion-derived allograft

Timeline

• Start date: 2024-06-23
• Primary completion: 2027-03-24
• Completion: 2027-09-08
• First posted: 2024-07-23
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States