Neuropathic Foot UlcerVHT1NCT04244201
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
A study testing Vaporous Hyperoxia Therapy in people with Neuropathic Foot Ulcer and Foot Ulcer, run by Vaporox.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Foot Ulcer, 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
- 31 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2005to 4 Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
- University of Texas Health Science Center classification: Grade 0, 1, and 2
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds
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.
Read the 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.
- Conditions
- Neuropathic Foot Ulcer, Foot Ulcer
- Being tested
- Vaporous Hyperoxia Therapy
- Keywords
- diabetic foot, leg ulcer, skin ulcer
- Medical subject headings
- Foot Ulcer, Diabetic Foot, Leg Ulcer, Skin Ulcer
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, Misty, WTS
1 hour of treatment, 4 times per week
| Study group | Role | What they receive |
|---|---|---|
| VHT treatment | Experimental | Patients will be treated with VHT for 1 hour four 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 healing rate at 12 weeks
The percent of subjects that achieved wound healing at 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Time to wound healing
Time to achieve complete wound healing
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start6 Jun 2005
- Primary completion1 Mar 2007
- Study completion4 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaporox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clifford J Wolf, DPM, Principal investigator, Wolf Podiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244201
- Sponsor's protocol ID
- VAPOROX-VHT100-01
- Acronym
- VHT1
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds
- ClinicalTrials.gov ID
- NCT04244201
- Acronym / sponsor ID
- VHT1 / VAPOROX-VHT100-01
- Conditions
- Neuropathic Foot Ulcer, Foot Ulcer
- Keywords
- diabetic foot, leg ulcer, skin ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- VaporoxIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2005 (actual)
- Primary completion
- 1 Mar 2007 (actual)
- Study completion
- 4 Oct 2007 (actual)
- First posted
- 28 Jan 2020 (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), 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.
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 1 hour four times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
- University of Texas Health Science Center classification: Grade 0, 1, and 2
Key exclusion criteria (13 listed)
- Ulcers above the medial and lateral malleoli
- Etiology of cancer/neoplastic
- Etiology of collagen vascular disease
- Etiology of gangrene
- Etiology of osteomyelitis (Grade 3)
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: VHT, Misty, WTS1 hour of treatment, 4 times per week | Device | VHT treatment |
Primary outcome
Wound healing rate at 12 weeks
Time frame: 12 weeks
The percent of subjects that achieved wound healing at 12 weeks
1 secondary outcome
Time to wound healing
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Clifford J Wolf, DPM principal investigator
Wolf Podiatry
Questions about this trial
What is this clinical trial studying?
A study testing Vaporous Hyperoxia Therapy in people with Neuropathic Foot Ulcer and Foot Ulcer, run by Vaporox.
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 2 inclusion and 13 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: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 healing rate at 12 weeks (time frame: 12 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 30 Jan 2020.