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

Primary Purpose

Neuropathic Foot Ulcer, Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaporous Hyperoxia Therapy
Sponsored by
Vaporox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Foot Ulcer focused on measuring diabetic foot, leg ulcer, skin ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    VHT treatment

    Arm Description

    Patients will be treated with VHT for 1 hour four times per week

    Outcomes

    Primary Outcome Measures

    Wound healing rate at 12 weeks
    The percent of subjects that achieved wound healing at 12 weeks

    Secondary Outcome Measures

    Time to wound healing
    Time to achieve complete wound healing

    Full Information

    First Posted
    January 23, 2020
    Last Updated
    January 28, 2020
    Sponsor
    Vaporox
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04244201
    Brief Title
    Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
    Acronym
    VHT1
    Official Title
    Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 6, 2005 (Actual)
    Primary Completion Date
    March 1, 2007 (Actual)
    Study Completion Date
    October 4, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vaporox

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuropathic Foot Ulcer, Foot Ulcer
    Keywords
    diabetic foot, leg ulcer, skin ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VHT treatment
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with VHT for 1 hour four times per week
    Intervention Type
    Device
    Intervention Name(s)
    Vaporous Hyperoxia Therapy
    Other Intervention Name(s)
    VHT, Misty, WTS
    Intervention Description
    1 hour of treatment, 4 times per week
    Primary Outcome Measure Information:
    Title
    Wound healing rate at 12 weeks
    Description
    The percent of subjects that achieved wound healing at 12 weeks
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Time to wound healing
    Description
    Time to achieve complete wound healing
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clifford J Wolf, DPM
    Organizational Affiliation
    Wolf Podiatry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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