Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the... | NCT04210609

Studies
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

NCT04210609

Sponsor

Vaporox

Status

Unknown status

Last Update Posted

Oct 11, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Diabetic Foot Ulcer

Interventions

Vaporous Hyperoxia Therapy

Countries

United States

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2021Actual

Primary Completion Date

Oct 3, 2022Estimated

Completion Date

Oct 3, 2022Estimated

First Submitted Date

Dec 19, 2019

First Submission Date that Met QC Criteria

Dec 20, 2019

First Posted Date

Dec 24, 2019Actual

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

Oct 4, 2021

Last Update Posted Date

Oct 11, 2021Actual

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) for the treatment of Diabetic Foot Ulcers.

Detailed Description

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VHT treatment	Experimental	Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week	Device: Vaporous Hyperoxia Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaporous Hyperoxia Therapy	Device	55 minutes of treatment, 2 times per week	VHT treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound closure rate at 20 weeks	The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage	20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Wound closure rate at 12 weeks	The percentage of subjects that achieved complete wound closure by week 12, where wound closure is defined by complete re-epithelialization without drainage	12 weeks
Time to 50%, 75%, 100% wound closure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
Wound has resisted healing with standard wound care for at least 6 weeks
No symptoms of sepsis
Able to maintain reasonable nutrition and hydration
Able to maintain adequate home care between treatment visits
Able to understand and follow basic wound care instructions, or has caregiver who can assist

Exclusion Criteria:

Skin wounds cancer/neoplastic etiology
Wounds that involve osteomyelitis or tendon involvement
Diagnosis of methicillin resistant staph aureus by wound swab
Acute skin conditions
Surgery within 30 days of study onset
Wounds where the end cannot be probed
Participation in another clinical trial within 120 days prior to study onset
Non-compliant patients
Pregnancy
Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dustin Kruse, DPM	Rocky Mountain Foot and Ankle Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rock Canyon Foot and Ankle Clinic		Castle Rock	Colorado	80109	United States
Rocky Mountain Foot and Ankle Center

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided