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New treatment option for Venous Leg Ulcer (VLU)
Official title Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
ClinicalTrials.gov ID: NCT06754735
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ 18 years and able to provide written informed consent
- Patients who have a chronic venous leg ulcer (VLU) below the knee at or above the malleolus determined to be due to underlying venous disease
- Venous reflux ≥ 500 mil sec/superficial or 1 sec/deep or venous mapping after interventions following a vascular procedure
- VLU of ≥ 1.5cm2 and ≤ 50cm2 after debridement at study enrolment i.e. Screening visit
- \ Cluster wounds where the sum of the full thickness ulcer area must be ≤ 50cm2
You likely can't join if
- Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy
- Acute thrombophlebitis or Deep Vein Thrombosis (DVT) and within three months preceding study entry
- Subject awaiting venous ablation or is less than 30 days post ablation
- Surgery during three months prior to study entry (such as abdominal, gynecological, hip or knee replacement)
- Wound etiology of uncertain origin or history or prior diagnosis of Systemic Lupus Erythematosus, Burger's Disease, Pyoderma Gangrenosum or other...
- Documented evidence of osteomyelitis on any part of affected limb
See the full eligibility criteria
- Adults ≥ 18 years and able to provide written informed consent
- Patients who have a chronic venous leg ulcer (VLU) below the knee at or above the malleolus determined to be due to underlying venous disease
- Venous reflux ≥ 500 mil sec/superficial or 1 sec/deep or venous mapping after interventions following a vascular procedure
- VLU of ≥ 1.5cm2 and ≤ 50cm2 after debridement at study enrolment i.e. Screening visit
- \ Cluster wounds where the sum of the full thickness ulcer area must be ≤ 50cm2
- Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry
- The index ulcer has been treated with CCD of at least 30mmHg for ≥ 6 weeks prior to screening.
- Adequate perfusion with Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry AND TcpO2 \> 30mmHg OR Biphasic arterial duplex below the knee OR Toe...
- Wound size reduction in a 2-week run-in period of ≤ 30%
- Subject understands and is willing to participate in the clinical study and comply with weekly visits and follow up regime
- Subject has read and signed IRB/EC approved ICF before screening procedures commence
- Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy
- Acute thrombophlebitis or Deep Vein Thrombosis (DVT) and within three months preceding study entry
- Subject awaiting venous ablation or is less than 30 days post ablation
- Surgery during three months prior to study entry (such as abdominal, gynecological, hip or knee replacement)
- Wound etiology of uncertain origin or history or prior diagnosis of Systemic Lupus Erythematosus, Burger's Disease, Pyoderma Gangrenosum or other inflammatory ulceration, vasculitis
- Documented evidence of osteomyelitis on any part of affected limb
- Index ulcer has exposed bone, muscle and tendon
- Index ulcer exhibits signs of unmanaged wound infection or severe clinical infection that requires hospitalization or immediate surgical intervention
- BMI \> 45
- Uncontrolled diabetes: HbA1c \> 12% within 60 days of screening
- Renal dialysis or of screening EGFR less than 30 mg/dl
- NYHA Class IV
- Peripheral arterial reconstruction/revascularization on the affected limb within the last 30 days
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids \> 10mg daily dose, immunosuppressive agents).
- Active systemic treatment for malignancy
- History of radiation at the ulcer site
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayer cell therapy, dermal substitute, extracellular matrix) within 14 days before screening
- Subject participated in another investigational device, drug or biological trial within four weeks prior to study entry
- Subject may not be pregnant or breastfeeding at the time of treatment
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.