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NCT06754735 · ClinicalTrials.gov registry record · Phase 4
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
A Phase 4 study of Venous Leg Ulcer (VLU), sponsored by AOTI.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 212
- Enrollment target
- 1
- Study location
NCT06754735 is a Phase 4 study of Venous Leg Ulcer (VLU) that is actively recruiting participants, run by AOTI. The registered enrollment target is 212 participants, roughly in line with the 203-participant average among 6 other Venous Leg Ulcer (VLU) trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06754735, a Phase 4 study of Venous Leg Ulcer (VLU), is actively recruiting participants, sponsored by AOTI.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 212 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. Following a 2-week run-in period with SOC and after meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio with TWO2 therapy or sham control therapy plus SOC. Participants will enter the intervention period of up to 16-weeks, followed by a long-term follow-up period of 52 weeks post randomization.
Conditions Studied
Interventions
- DEVICE Topical Wound Oxygen Therapy
- DEVICE Sham Control Topical Wound Oxygen
Study Locations (1)
New York
- Vascular Institute of New York - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2028-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06754735
The ClinicalTrials.gov registry entry for NCT06754735 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 203-participant average among 6 other Venous Leg Ulcer (VLU) trials with a reported enrollment target. The listed sponsor is AOTI, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Venous Leg Ulcer (VLU) appearing as the primary indexed condition, and to 2 interventions - of which Topical Wound Oxygen Therapy is the first listed.
NCT06754735 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06754735 about?
NCT06754735 is a clinical study titled "Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers". The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. ...
What is the current status of trial NCT06754735?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 212 participants. The study started on 2025-01-15. Estimated completion is 2028-06.
What conditions does trial NCT06754735 study?
This clinical trial studies the following conditions: Venous Leg Ulcer (VLU).
What interventions are being tested in trial NCT06754735?
The interventions under investigation include: Topical Wound Oxygen Therapy (DEVICE), Sham Control Topical Wound Oxygen (DEVICE).
Who is sponsoring clinical trial NCT06754735?
This trial is sponsored by AOTI, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06754735 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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