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

Status unconfirmed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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

Key facts

Study ID

NCT04210609

Run by

Vaporox

People needed

30

Starts

2021-10-04

Expected to finish

2022-10-03

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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