Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers

Part of paid clinical trials in New York, New York.

Sponsor
AOTI Ltd.
Study ID
NCT06754735
Phase
PHASE4
Status
Recruiting
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Conditions

  • Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Topical Wound Oxygen Therapy — DEVICE
    The active intervention is the application of the Topical Wound Oxygen device that supplies cyclical oxygen pressure directly to the wound site within a sealed environment.
  • Sham Control Topical Wound Oxygen — DEVICE
    The sham control intervention is the application of Topical Wound Oxygen device that supplies topical room air to the wound site within a sealed environment.

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Topical Wound Oxygen Therapy Device
    Topical Wound Oxygen (TWO2) device in combination with the extremity chamber delivers oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with oxygen for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.
  • Sham Comparator: Sham Control Topical Wound Oxygen (TWO2) device
    A Sham Control Topical Wound Oxygen (TWO2) device in combination with the extremity chamber that does not deliver oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with room air for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.

Primary Outcome Measure

Incidence of complete wound closure within 16 weeks with the use of Topical Wound Oxygen Therapy (TWO2) [ Time Frame: From Baseline to16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vascular Institute of New YorkNew YorkNew York10016-

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Vascular Institute of New York· New York, NY

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