Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

Detailed Description
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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.

Official Title
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Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Vaporous Hyperoxia Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VHT treatment<br>Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week | Device: Vaporous Hyperoxia Therapy<br>* 55 minutes of treatment, 2 times per week<br>* Other names: VHT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure rate at 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 | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure rate at 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 | 12 weeks | 
| Time to 50%, 75%, 100% wound closure | Time to percent reduction in volume (length x width x depth) from baseline | Up to 20 weeks |