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

Diabetic Foot Ulcer Clinical Trial

— VHTDFU2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04210609
• Other study ID #: VAPOROX-VHT100-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2021
• Source: Vaporox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Hyperoxia

Intervention

Device:
• Vaporous Hyperoxia Therapy
55 minutes of treatment, 2 times per week

Locations

Country	Name	City	State
United States	Rock Canyon Foot and Ankle Clinic	Castle Rock	Colorado
United States	Colorado Foot and Ankle	Denver	Colorado
United States	Rocky Mountain Foot and Ankle Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Vaporox

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to 50%, 75%, 100% wound closure	Time to percent reduction in volume (length x width x depth) from baseline	Up to 20 weeks

External Links

•   JAPMA publication of second clinical study