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NCT06764953 · ClinicalTrials.gov registry record · NA
Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone
A NA study of Venous Leg Ulcers, sponsored by Skye Biologics Holdings.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06764953: Recruiting NA study of Venous Leg Ulcers, sponsored by Skye Biologics Holdings.
NCT06764953 is a NA study of Venous Leg Ulcers that is actively recruiting participants, run by Skye Biologics Holdings. The registered enrollment target is 100 participants, below the 145-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06764953, a NA study of Venous Leg Ulcers, 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 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) * 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 NCT06764953 shows while recruiting
NCT06764953 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 145-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Venous Leg Ulcers appearing as the primary indexed condition, and to 2 interventions - of which E-GRAFT ™ is the first listed.
NCT06764953 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06764953 about?
NCT06764953 is a clinical study titled "Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone". The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with 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 (...
What is the current status of trial NCT06764953?
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 NCT06764953 study?
This clinical trial studies the following conditions: Venous Leg Ulcers.
What interventions are being tested in trial NCT06764953?
The interventions under investigation include: E-GRAFT ™ (OTHER), FIBRACOL™ (DEVICE).
Who is sponsoring clinical trial NCT06764953?
This trial is sponsored by Skye Biologics Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06764953 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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