Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds

NCT ID: NCT04244201

Last Updated: 2020-01-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-06

Study Completion Date

2007-10-04

Brief Summary

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The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

Detailed Description

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The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

Conditions

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Neuropathic Foot Ulcer 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 1 hour four times per week

Group Type EXPERIMENTAL

Vaporous Hyperoxia Therapy

Intervention Type DEVICE

1 hour of treatment, 4 times per week

Interventions

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Vaporous Hyperoxia Therapy

1 hour of treatment, 4 times per week

Intervention Type DEVICE

Other Intervention Names

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VHT Misty WTS

Eligibility Criteria

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Inclusion Criteria

* Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
* University of Texas Health Science Center classification: Grade 0, 1, and 2

Exclusion Criteria

* Ulcers above the medial and lateral malleoli
* Etiology of cancer/neoplastic
* Etiology of collagen vascular disease
* Etiology of gangrene
* Etiology of osteomyelitis (Grade 3)
* Etiology of thermal burns
* Etiology of radiation injury
* Pregnancy
* Acute skin conditions
* Inadequate perfusion to support treatment
* Wounds where the end cannot be probed
* Wounds covered with petroleum based dressing
* Non-compliant patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vaporox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clifford J Wolf, DPM

Role: PRINCIPAL_INVESTIGATOR

Wolf Podiatry

Other Identifiers

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VAPOROX-VHT100-01

Identifier Type: -

Identifier Source: org_study_id

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