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UNKNOWNNANCT04210609

Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic 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.

Lead sponsor: Vaporox•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Vaporox

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.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 11, 2021Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment30

Start dateOct 2021

Last updatedOct 11, 2021

Condition

Diabetic Foot Ulcer

Locations shown

Rock Canyon Foot and Ankle Clinic

Castle Rock, Colorado

Rocky Mountain Foot and Ankle Center

Denver, Colorado

Colorado Foot and Ankle

Denver, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2021Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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