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Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

NCT06515093 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer

Interventions

OTHER

PelloGraft

dual layer amnion/chorion-derived allograft

OTHER

SanoGraft

single layer amnion-derived allograft

Sponsors & Collaborators

  • Surgenex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-23
Primary Completion
2027-03-24
Completion
2027-09-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515093 on ClinicalTrials.gov