Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot... | NCT04244201

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

NCT04244201

Sponsor

Vaporox

Status

Completed

Last Update Posted

Jan 30, 2020Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Neuropathic Foot Ulcer
Foot Ulcer

Interventions

Vaporous Hyperoxia Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2005Actual

Primary Completion Date

Mar 1, 2007Actual

Completion Date

Oct 4, 2007Actual

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 27, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2020

Last Update Posted Date

Jan 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VHT treatment	Experimental	Patients will be treated with VHT for 1 hour four times per week	Device: Vaporous Hyperoxia Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaporous Hyperoxia Therapy	Device	1 hour of treatment, 4 times per week	VHT treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clifford J Wolf, DPM	Wolf Podiatry	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016523	Foot Ulcer
D017719	Diabetic Foot
D007871	Leg Ulcer
D012883	Skin Ulcer

Ancestor Terms

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D003925	Diabetic Angiopathies

Browse Leaves

Not provided

Browse Branches

Not provided