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NCT06767501 · ClinicalTrials.gov registry record · NA
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
A NA study of Diabetic Foot Ulcers (DFUs), sponsored by Skye Biologics Holdings.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06767501: Recruiting NA study of Diabetic Foot Ulcers (DFUs), sponsored by Skye Biologics Holdings.
NCT06767501 is a NA study of Diabetic Foot Ulcers (DFUs) that is actively recruiting participants, run by Skye Biologics Holdings. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06767501, a NA study of Diabetic Foot Ulcers (DFUs), is actively recruiting participants, sponsored by Skye Biologics Holdings.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection
Primary Outcome
Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements
Conditions Studied
Interventions
- OTHER E-GRAFT ™
- DEVICE FIBRACOL™
Study Locations (1)
Virginia
- Professional Education and Research Institute - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-28 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT06767501 shows while recruiting
NCT06767501 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diabetic Foot Ulcers (DFUs) appearing as the primary indexed condition, and to 2 interventions - of which E-GRAFT ™ is the first listed.
NCT06767501 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06767501 about?
NCT06767501 is a clinical study titled "Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care". The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse ev...
What is the current status of trial NCT06767501?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-12-28. Estimated completion is 2025-12.
What conditions does trial NCT06767501 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcers (DFUs).
What interventions are being tested in trial NCT06767501?
The interventions under investigation include: E-GRAFT ™ (OTHER), FIBRACOL™ (DEVICE).
Who is sponsoring clinical trial NCT06767501?
This trial is sponsored by Skye Biologics Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06767501 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers (DFUs)
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 NCT06767501's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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