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

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Vaporous Hyperoxia Therapy

• Registration Number: NCT04210609
• Lead Sponsor: Vaporox

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.

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Status Verified: 2021-10
• Study Start: 2021-10-04
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11
• Primary Completion: 2022-10-03
• Study Completion: 2022-10-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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 55 minutes at a minimum frequency of 2 times per week

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to 50%, 75%, 100% wound closure	Up to 20 weeks	Time to percent reduction in volume (length x width x depth) from baseline
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

Trial Locations

Locations (3)

Rocky Mountain Foot and Ankle Center; 🇺🇸 Denver, Colorado, United States

Colorado Foot and Ankle; 🇺🇸 Denver, Colorado, United States

Rock Canyon Foot and Ankle Clinic; 🇺🇸 Castle Rock, Colorado, United States