Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
Not Applicable
Completed
- Conditions
- Neuropathic Foot UlcerFoot Ulcer
- Interventions
- Device: Vaporous Hyperoxia Therapy
- Registration Number
- NCT04244201
- Lead Sponsor
- Vaporox
- Brief Summary
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.
- Detailed Description
The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
- University of Texas Health Science Center classification: Grade 0, 1, and 2
Exclusion Criteria
- Ulcers above the medial and lateral malleoli
- Etiology of cancer/neoplastic
- Etiology of collagen vascular disease
- Etiology of gangrene
- Etiology of osteomyelitis (Grade 3)
- Etiology of thermal burns
- Etiology of radiation injury
- Pregnancy
- Acute skin conditions
- Inadequate perfusion to support treatment
- Wounds where the end cannot be probed
- Wounds covered with petroleum based dressing
- Non-compliant patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VHT treatment Vaporous Hyperoxia Therapy Patients will be treated with VHT for 1 hour four times per week
- Primary Outcome Measures
Name Time Method Wound healing rate at 12 weeks 12 weeks The percent of subjects that achieved wound healing at 12 weeks
- Secondary Outcome Measures
Name Time Method Time to wound healing up to 12 weeks Time to achieve complete wound healing