Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds (VHT1)

January 28, 2020 updated by: Vaporox

Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VHT treatment
Patients will be treated with VHT for 1 hour four times per week
Device: Vaporous Hyperoxia Therapy
1 hour of treatment, 4 times per week
Other Names:
  • VHT
  • Misty
  • WTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing rate at 12 weeks
Time Frame: 12 weeks
The percent of subjects that achieved wound healing at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wound healing
Time Frame: up to 12 weeks
Time to achieve complete wound healing
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaporox

Investigators

  • Principal Investigator: Clifford J Wolf, DPM, Wolf Podiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

October 4, 2007

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAPOROX-VHT100-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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