Back to resultsEffectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers (VHTDFU2)
Primary Purpose
Diabetic Foot Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaporous Hyperoxia Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
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
Sites / Locations
- Rock Canyon Foot and Ankle Clinic
- Rocky Mountain Foot and Ankle Center
- Colorado Foot and Ankle
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VHT treatment
Arm Description
Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Time to 50%, 75%, 100% wound closure
Time to percent reduction in volume (length x width x depth) from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04210609
Brief Title
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
Acronym
VHTDFU2
Official Title
Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Anticipated)
Study Completion Date
October 3, 2022 (Anticipated)
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot 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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VHT treatment
Arm Type
Experimental
Arm Description
Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week
Intervention Type
Device
Intervention Name(s)
Vaporous Hyperoxia Therapy
Other Intervention Name(s)
VHT
Intervention Description
55 minutes of treatment, 2 times per week
Primary Outcome Measure Information:
Title
Wound closure rate at 20 weeks
Description
The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Wound closure rate at 12 weeks
Description
The percentage of subjects that achieved complete wound closure by week 12, where wound closure is defined by complete re-epithelialization without drainage
Time Frame
12 weeks
Title
Time to 50%, 75%, 100% wound closure
Description
Time to percent reduction in volume (length x width x depth) from baseline
Time Frame
Up to 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin Kruse, DPM
Organizational Affiliation
Rocky Mountain Foot and Ankle Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rock Canyon Foot and Ankle Clinic
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Facility Name
Rocky Mountain Foot and Ankle Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Colorado Foot and Ankle
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
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