Foot Ulcer, Neuropathic Foot Ulcer
Conditions
Keywords
diabetic foot, leg ulcer, skin ulcer
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.
Interventions
1 hour of treatment, 4 times per week
Sponsors
Vaporox
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing rate at 12 weeks | 12 weeks | The percent of subjects that achieved wound healing at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound healing | up to 12 weeks | Time to achieve complete wound healing |
Outcome results
None listed