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NCT06693570 · ClinicalTrials.gov registry record · Phase 4
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
A Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers, sponsored by Kerecis.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06693570: Recruiting Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers, sponsored by Kerecis.
NCT06693570 is a Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers that is actively recruiting participants, run by Kerecis. The registered enrollment target is 150 participants, below the 213-participant average among 6 other Venous Leg Ulcer (VLU) trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06693570, a Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers, is actively recruiting participants, sponsored by Kerecis.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
Primary Outcome
The percentage of target ulcers achieving complete wound closure in 12 weeks
Conditions Studied
Interventions
- OTHER Standard of Care
- OTHER Intact Fish Skin Graft (IFSG) + Standard of Care
Study Locations (1)
Pennsylvania
- Serena Group- Monroeville - Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2026-11 |
| Phase | Phase 4 |
What NCT06693570 shows while recruiting
NCT06693570 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 213-participant average among 6 other Venous Leg Ulcer (VLU) trials with a reported enrollment target (30% lower).
The record links to 4 conditions, with Venous Leg Ulcer (VLU) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT06693570 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06693570 about?
NCT06693570 is a clinical study titled "Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers". The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
What is the current status of trial NCT06693570?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-11-25. Estimated completion is 2026-11.
What conditions does trial NCT06693570 study?
This clinical trial studies the following conditions: Venous Leg Ulcer (VLU), Venous Leg Ulcers, Venous Leg, Nonhealing Venous Leg Ulcer.
What interventions are being tested in trial NCT06693570?
The interventions under investigation include: Standard of Care (OTHER), Intact Fish Skin Graft (IFSG) + Standard of Care (OTHER).
Who is sponsoring clinical trial NCT06693570?
This trial is sponsored by Kerecis, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06693570 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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