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
Surgenex
180 participants
Jun 23, 2024
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
dual layer amnion/chorion-derived allograft
single layer amnion-derived allograft
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06515093