Diabetic UlcerNCT00871312
Evaluation of Topical Wound Oxygen (two2) Therapy
A study testing Topical wound oxygen therapy in people with Diabetic Ulcer, run by AOTI Ltd. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ulcer
- What is being tested?
- Topical wound oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2007to Dec 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject or legal representative has read, understands, and has signed the Institutional Review Board (IRB)-approved Informed COnsent Form (ICF) prior to enrollment in the study;
- Subject is 18 years of age or older;
- Subject has a current diagnosis of Type I or Type II diabetes mellitus;
- Subject has a diabetic lower extremity ulcer;
- Subject's index ulcer is at least 1.0cm2 in area;
- Subject's index ulcer is a superficial, partial or full thickness skin ulcer (Wagner Classification System I, II or III) which has been present for at least 4 weeks at the time of initial screening that has not improved with standard of care;
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- Subject's index ulcer appears to be free of sinus tracts and tunneling;
- Subject's index ulcer exhibits no signs of moderate or severe clinical infection;
- In the event of multiple wounds on the same foot, the index ulcer will be the largest ulcer meeting the other inclusion criteria;
- In the event of multiple wounds on the same foor, the index ulcer is at least 2 cm from any additional wound edge;
- Women of childbearing potential must not be pregnant or lactating;
- Subject and/or caregiver are willing and able to comply with all specified care and visit requirements, and subject has a reasonable expectation of completing the study;
- Subject must be fit to undertake the study trial in the opinion of the referring doctor
- Subject's Great Toe pressure is greater than 20mmHg.
Who cannot join
- Subject is currently enrolled in another investigational device or drug trial, or has been previously enrolled in investigative research for a device or pharmaceutical agent within the last 30 days;
- Subject's index ulcer has gangrene or gangrene is located on any part of the foot with the index ulcer;
- Subject has an acute and/or active Deep Vein Thrombosis;
- Subject is currently receiving or has received in the last six (6) months radiation or chemotherapy;
- Subject has received growth factor therapy within seven (7) days prior to initial screening;
- Subject has a significant medical condition that would impair wound healing, for example: severe liver disease, aplastic anemia, scleroderma, malnutrition, malignancy, etc;
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- Subject has known or suspected osteomyelitis;
- Other than debridement, the underlying wound pathology requires surgical correction for the index ulcer to heal;
- Subject is receiving or has received corticosteroids (all applications), immunosuppressive agents, or other drugs that would impair wound healing within seven (7) days prior to initial screening or is anticipated to require them during the course of the study;
- Subject has an acute or active Charcot foot per clinical and radiology results or significant bony prominences that would preclude adequate off-loading with the standard off-loading device. The presence of Charcot foot in itself does not exclude the subject;
- Subject has known HIV, hepatitis, active cancer (except basal cell and non-melanoma skin cancer), or a bleeding disorder;
- Subject is undergoing renal dialysis;
- Subject suffers from known alcohol or drug abuse;
- Use of the standard off-loading device is contra-indicated or cannot be appropriately fitted to the subject.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Community Dermatology & Wound Healing Clinic
Mississauga, Ontario, L4Y 1A6
Wound Care Clinic
Saint Catherines, Ontario, L2R2P7
About this study
Official title: A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
Read the detailed description
The AOTI two2 therapy trial is a randomized, double-blinded, parallel group, placebo-controlled, multi-center study intended to evaluate the efficacy of Topical Wound Oxygen (two2) therapy in relation to placebo when added to standard of care in the treatment of diabetic lower extremity ulcers.
- Conditions
- Diabetic Ulcer
- Being tested
- Topical wound oxygen therapy, Topical wound oxygen Placebo
- Keywords
- diabetes, diabetic, wound, ulcer, lower extremity, foot, oxygen, hyperbaric, topical wound oxygen
- Medical subject headings
- Diabetes Mellitus, Wounds and Injuries, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical wound oxygen therapyDevice
90 minutes 4 days per week Active Topical Oxygen Therapy
Topical wound oxygen PlaceboDevice
90 mins per day 4 days per week Placebo Therapy
| Study group | Role | What they receive |
|---|---|---|
| Topical Wound Oxygen Therapy | Active comparator | Subjects will receive four 90 minute treatments of two2 therapy per week Receives: Device: Topical wound oxygen therapy |
| Placebo Therapy | Placebo comparator | Subjects will receive four 90 minute treatments of Placebo two2 therapy per week Receives: Device: Topical wound oxygen Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
Measured: 12 Weeks
Secondary outcomes (5)
The time to wound closure
Measured: Variable
The degree of wound closure
Measured: 4, 8, and 12 weeks
The percentage of tissue types
Measured: 4, 8 and 12 weeks
The type and amount of wound drainage or exudates
Measured: 4, 8 and 12 weeks
The level of wound pain
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Low recruitment rate meaning unable to complete the study in a timely manner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOTI Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura E Edsberg, Ph.D., Principal investigator, Daamen College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871312
- Sponsor's protocol ID
- AOTI-001
- Status last verified
- Jan 2014
- First submitted
- 26 Mar 2009
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers
- ClinicalTrials.gov ID
- NCT00871312
- Acronym / sponsor ID
- AOTI-001
- Conditions
- Diabetic Ulcer
- Keywords
- diabetes, diabetic, wound, ulcer, lower extremity, foot, oxygen, hyperbaric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate meaning unable to complete the study in a timely manner
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AOTI Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Mar 2009 (estimated)
- 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 efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
Detailed description
The AOTI two2 therapy trial is a randomized, double-blinded, parallel group, placebo-controlled, multi-center study intended to evaluate the efficacy of Topical Wound Oxygen (two2) therapy in relation to placebo when added to standard of care in the treatment of diabetic lower extremity ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Wound Oxygen Therapy | Active comparator | Device: Topical wound oxygen therapySubjects will receive four 90 minute treatments of two2 therapy per week |
| Placebo Therapy | Placebo comparator | Device: Topical wound oxygen PlaceboSubjects will receive four 90 minute treatments of Placebo two2 therapy per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject or legal representative has read, understands, and has signed the Institutional Review Board (IRB)-approved Informed COnsent Form (ICF) prior to enrollment in the study;
- Subject is 18 years of age or older;
- Subject has a current diagnosis of Type I or Type II diabetes mellitus;
- Subject has a diabetic lower extremity ulcer;
- Subject's index ulcer is at least 1.0cm2 in area;
Key exclusion criteria (14 listed)
- Subject is currently enrolled in another investigational device or drug trial, or has been previously enrolled in investigative research for a device or pharmaceutical agent within the last 30 days;
- Subject's index ulcer has gangrene or gangrene is located on any part of the foot with the index ulcer;
- Subject has an acute and/or active Deep Vein Thrombosis;
- Subject is currently receiving or has received in the last six (6) months radiation or chemotherapy;
- Subject has received growth factor therapy within seven (7) days prior to initial screening;
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 |
|---|---|---|
| Topical wound oxygen therapy90 minutes 4 days per week Active Topical Oxygen Therapy | Device | Topical Wound Oxygen Therapy |
| Topical wound oxygen Placebo90 mins per day 4 days per week Placebo Therapy | Device | Placebo Therapy |
Primary outcome
Wound closure
Time frame: 12 Weeks
5 secondary outcomes
The time to wound closure
Time frame: Variable
The degree of wound closure
Time frame: 4, 8, and 12 weeks
The percentage of tissue types
Time frame: 4, 8 and 12 weeks
The type and amount of wound drainage or exudates
Time frame: 4, 8 and 12 weeks
The level of wound pain
Time frame: 4, 8 and 12 weeks
Results and safety
The study was stopped early (reason given: Low recruitment rate meaning unable to complete the study in a timely manner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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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.
Laura E Edsberg, Ph.D. principal investigator
Daamen College
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical wound oxygen therapy in people with Diabetic Ulcer, run by AOTI Ltd. at 3 sites in 2 countries.
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 14 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Jan 2014. 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 Canada, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Low recruitment rate meaning unable to complete the study in a timely manner). 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 (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 10 Jan 2014.