NCT04244201

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2007

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

January 23, 2020

Last Update Submit

January 28, 2020

Conditions

Neuropathic Foot UlcerFoot Ulcer

Keywords

diabetic footleg ulcerskin ulcer

Outcome Measures

Primary Outcomes (1)

  • Wound healing rate at 12 weeks

    The percent of subjects that achieved wound healing at 12 weeks

    12 weeks

Secondary Outcomes (1)

  • Time to wound healing

    up to 12 weeks

Study Arms (1)

VHT treatment

EXPERIMENTAL

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

Device: Vaporous Hyperoxia Therapy

Interventions

Vaporous Hyperoxia TherapyDEVICE

1 hour of treatment, 4 times per week

Also known as: VHT, Misty, WTS
VHT treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Foot UlcerDiabetic FootLeg UlcerSkin Ulcer

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Clifford J Wolf, DPM

    Wolf Podiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 28, 2020

Study Start

June 6, 2005

Primary Completion

March 1, 2007

Study Completion

October 4, 2007

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share