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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-10-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VHT treatment

Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week

Group Type EXPERIMENTAL

Vaporous Hyperoxia Therapy

Intervention Type DEVICE

55 minutes of treatment, 2 times per week

Interventions

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Vaporous Hyperoxia Therapy

55 minutes of treatment, 2 times per week

Intervention Type DEVICE

Other Intervention Names

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VHT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No