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NCT06515093 · ClinicalTrials.gov registry record · NA
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
A NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Surgenex.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 2
- Study locations
NCT06515093: Recruiting NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Surgenex.
NCT06515093 is a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer that is actively recruiting participants, run by Surgenex. The registered enrollment target is 180 participants, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (29% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06515093, a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, is actively recruiting participants, sponsored by Surgenex.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER PelloGraft
- OTHER SanoGraft
Study Locations (2)
California
- ILD Research - Vista
Oklahoma
- Tulsa Wound Center - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-06-23 |
| Est. Completion | 2026-09-09 |
| Phase | NA |
What NCT06515093 shows while recruiting
NCT06515093 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which PelloGraft is the first listed.
NCT06515093 reports a single indexed study location in California, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06515093 about?
NCT06515093 is a clinical study titled "Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC". 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...
What is the current status of trial NCT06515093?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2024-06-23. Estimated completion is 2026-09-09.
What conditions does trial NCT06515093 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Venous Leg Ulcer.
What interventions are being tested in trial NCT06515093?
The interventions under investigation include: PelloGraft (OTHER), SanoGraft (OTHER).
Who is sponsoring clinical trial NCT06515093?
This trial is sponsored by Surgenex, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06515093 being conducted?
This trial has 2 study locations across California, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06515093's enrollment target sits among peer trials
180 19th of 67 higher than 48 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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