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

Vaporox31 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuropathic Foot Ulcer Foot Ulcer

Interventions

Vaporous Hyperoxia TherapyDEVICE

1 hour of treatment, 4 times per week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Wound healing rate at 12 weeks

The percent of subjects that achieved wound healing at 12 weeks

Time frame: 12 weeks

Secondary Outcomes

Time to wound healing

Time to achieve complete wound healing

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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