Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 4 study of Venous Leg Ulcer (VLU), sponsored by AOTI.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage incidence of complete wound closure defined as 100% skin re-epithelialization without the need for wound dressing that is confirmed by 2 consecutive study visits 2 weeks apart.
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 |
What NCT06754735 shows while recruiting
NCT06754735 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 203-participant average among 6 other Venous Leg Ulcer (VLU) trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Venous Leg Ulcer (VLU)
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.
-
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
RECRUITING · Phase 4
-
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
RECRUITING · Phase 4
-
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
RECRUITING · Phase 4
-
Evaluating the Durability of Closure for Venous Leg Ulcers
RECRUITING
-
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
RECRUITING · Phase 3
-
A Real World Data Collection OF Human Amniotic Membrane(s) ON Diabetic Foot Ulcers, Venous LEG Ulcers, Pressure Ulcers AND Post Operative Wounds
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04228978 · 212 participants · NA
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
- NCT04725721 · 212 participants · NA
Testing FIRST in Youth Outpatient Psychotherapy
- NCT06257576 · 212 participants · Phase 3
Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter
- NCT06456593 · 212 participants · Phase 2
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI