Diabetic Foot Ulcer
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
Detailed description
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.
Interventions
55 minutes of treatment, 2 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 75 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3 * Wound has resisted healing with standard wound care for at least 6 weeks * No symptoms of sepsis * Able to maintain reasonable nutrition and hydration * Able to maintain adequate home care between treatment visits * Able to understand and follow basic wound care instructions, or has caregiver who can assist
Exclusion criteria
* Skin wounds cancer/neoplastic etiology * Wounds that involve osteomyelitis or tendon involvement * Diagnosis of methicillin resistant staph aureus by wound swab * Acute skin conditions * Surgery within 30 days of study onset * Wounds where the end cannot be probed * Participation in another clinical trial within 120 days prior to study onset * Non-compliant patients * Pregnancy * Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure rate at 20 weeks | 20 weeks | The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure rate at 12 weeks | 12 weeks | The percentage of subjects that achieved complete wound closure by week 12, where wound closure is defined by complete re-epithelialization without drainage |
| Time to 50%, 75%, 100% wound closure | Up to 20 weeks | Time to percent reduction in volume (length x width x depth) from baseline |
Countries
United States
Outcome results
None listed