Diabetic Foot UlcerVHTDFU2NCT04210609
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
A study testing Vaporous Hyperoxia Therapy in people with Diabetic Foot Ulcer, run by Vaporox at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Vaporous Hyperoxia Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2021to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rock Canyon Foot and Ankle Clinic
Castle Rock, Colorado, 80109
Rocky Mountain Foot and Ankle Center
Denver, Colorado, 80033
Colorado Foot and Ankle
Denver, Colorado, 80210
About this study
Official title: Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Vaporous Hyperoxia Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaporous Hyperoxia TherapyDevice
Also called VHT
55 minutes of treatment, 2 times per week
| Study group | Role | What they receive |
|---|---|---|
| VHT treatment | Experimental | Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week Receives: Device: Vaporous Hyperoxia Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 weeks
Secondary outcomes (2)
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
Measured: 12 weeks
Time to 50%, 75%, 100% wound closure
Time to percent reduction in volume (length x width x depth) from baseline
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start4 Oct 2021
- Primary completion3 Oct 2022 (estimated)
- Study completion3 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaporox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dustin Kruse, DPM, Principal investigator, Rocky Mountain Foot and Ankle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210609
- Sponsor's protocol ID
- VAPOROX-VHT100-02
- Acronym
- VHTDFU2
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2019
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
- ClinicalTrials.gov ID
- NCT04210609
- Acronym / sponsor ID
- VHTDFU2 / VAPOROX-VHT100-02
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VaporoxIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 Oct 2022 (estimated)
- Study completion
- 3 Oct 2022 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VHT treatment | Experimental | Device: Vaporous Hyperoxia TherapyPatients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaporous Hyperoxia TherapyAlso: VHT55 minutes of treatment, 2 times per week | Device | VHT treatment |
Primary outcome
Wound closure rate at 20 weeks
Time frame: 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
2 secondary outcomes
Wound closure rate at 12 weeks
Time frame: 12 weeks
Time to 50%, 75%, 100% wound closure
Time frame: Up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin Kruse, DPM principal investigator
Rocky Mountain Foot and Ankle Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaporous Hyperoxia Therapy in people with Diabetic Foot Ulcer, run by Vaporox at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure rate at 20 weeks (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.