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Completed

NCT Number: NCT04244201

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

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Key information

Conditions

Neuropathic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaporous Hyperoxia Therapy

Device

1 hour of treatment, 4 times per week

Other names: VHT, Misty, WTS

Primary outcomes

  1. Wound healing rate at 12 weeks

    Time frame: 12 weeks

    The percent of subjects that achieved wound healing at 12 weeks

Secondary outcomes

  1. Time to wound healing

    Time frame: up to 12 weeks

    Time to achieve complete wound healing

Sponsors and collaborators

Lead sponsor

Vaporox

Industry

Registry information

Official study title

Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds

Acronym: VHT1

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 28, 2020
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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