The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
55 minutes of treatment, 2 times per week
Rock Canyon Foot and Ankle Clinic
Castle Rock, Colorado, United States
Rocky Mountain Foot and Ankle Center
Denver, Colorado, United States
Colorado Foot and Ankle
Denver, Colorado, United States
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
Time frame: 20 weeks
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
Time frame: 12 weeks
Time to 50%, 75%, 100% wound closure
Time to percent reduction in volume (length x width x depth) from baseline
Time frame: Up to 20 weeks
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