Diabetes MellitusPhase 4HBOTNCT00621608
Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
A Phase 4 study testing Hyperbaric Oxygen Therapy in people with Diabetes Mellitus and Chronic Ulcers of the Lower Limb, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Chronic Ulcers of the Lower Limb
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Apr 2013
- Phase
- Phase 4
- 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
- Age > 18 years
- Type 1 or 2 Diabetes Mellitus
- Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks.
Who cannot join
- Impending urgent amputation due to ongoing or exacerbated infection;
- Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed;
- Dialysis-dependent renal failure;
- Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity;
- History of chemotherapy with use of Bleomycin;
- Participation in another investigative drug or device trial currently or within the last 30 days;
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- Current candidates for vascular surgery, angioplasty or stenting;
- Major large vessel disease;
- Undergone vascular surgery or angioplasty within the last 3 months;
- Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Judy Dan Wound Care Centre/University Health Network
Toronto, Ontario, M2R 1N5
About this study
Official title: A Prospective, Double-blind, Randomized, Controlled Clinical Trial Comparing Standard Wound Care With Adjunctive Hyperbaric Oxygen Therapy (HBOT) to Standard Wound Care Only for the Treatment of Chronic, Non-healing Ulcers of the Lower Limb in Patients With Diabetes Mellitus.
The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs.
Read the detailed description
People with diabetes mellitus and non-healing ulcers of the lower limb are at higher risk of amputation. Current standard care for foot ulcers includes maintaining optimal blood glucose levels, use of debridement, antibacterials, dressings, antibiotics for infection; adequate nutrition; pressure relief and amputation. There has been an increased interest in the use of hyperbaric oxygen therapy (HBOT) as an adjunctive treatment for diabetic ulcers. HBOT is an established technology which currently is an accepted treatment of chronic diabetic ulcers in Ontario and physicians who provide this service are reimbursed under the current Ontario Health Insurance Plan (OHIP). However there are only a few facilities that can provide this service. In addition, results of published HBOT studies are inconsistent. The current study will provide quality efficacy data on the use of HBOT as an adjunctive therapy. As this study has been recommended by the Ontario Health Technology Advisory Committee (OHTAC), the results of the study will be used to make policy decisions regarding the funding and further utilization of HBOT therapy for people with diabetes mellitus with ulcers of the lower limb in the province. If the results are favorable towards HBOT in the treatment of diabetic ulcers, potential expansion and availability of this and other programs maybe be possible. A randomized placebo control trial evaluating HBOT, to the best of our knowledge has not been completed in this area and will provide much needed information to the scientific community.
- Being tested
- Hyperbaric Oxygen Therapy, Placebo Hyperbaric Oxygen Chamber
- Keywords
- Chronic ulcers, Diabetes, Hyperbaric Oxygen Therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
Hyperbaric Oxygen Therapy (HBOT) will be provided 5 days per week for 6 weeks for a total of 30 treatments on average. Subjects will be placed into the hyperbaric chamber for approximately 90 minutes of HBOT at 2.4 ATA (partial pressure of oxygen = 1,800 mmHg) when inside the chamber. Subjects will receive dressing changes as required per standard of care.
Placebo Hyperbaric Oxygen ChamberProcedure or surgery
Patients will receive HBOT placebo 5 days per week for 6 weeks for a total of 30 treatments. Each patient will be placed into the hyperbaric chamber and will receive 90 minutes of room air while inside the chamber and the initial flow of air into the chamber will produce a small increase in pressure (0.3 ATA partial pressure of oxygen = 210 mmHg) which will then be released over a period of 10 minutes. Subjects will receive dressings changes as required per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hyperbaric Oxygen Therapy Receives: Procedure: Hyperbaric Oxygen Therapy |
| 2 | Sham comparator | Placebo Hyperbaric Oxygen Chamber Receives: Procedure: Placebo Hyperbaric Oxygen Chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization.
Measured: up to 12 weeks after randomization
Secondary outcomes (6)
Wound healing: difference in wound measurements (i.e. depth, length, width and extent of surface area); reduction in Wagner Classification Score; proportion of wound closed at 12 weeks of any time interval prior to end point; time to healing (days)
Measured: up to 12 weeks after randomization
Effectiveness: maintenance on therapy (discontinuation rates); and secondary prevention interventions (confounding variables that may influence primary outcome such as diabetes control)
Measured: up to 12 weeks after Randomziation
Safety: Major morbidity (infection requiring hospitalization, renal failure); wound interventions during study (debridement, surgery); Complications related to HBOT (seizure, pulmonary syndromes, vision disturbance; and all cause mortality
Measured: From enrollment up to 1 year after randomization
Healthcare resource utilization: wound dressing materials; healthcare provider visits; inpatient hospital admissions; complex continuing care/rehabilitation; drug therapy; mobility assistive devices
Measured: From enrollment to study up to 1 year after randomization
Quality of life: assessed by Standard Form 36 (SF-36) domain scores; EuroQoL 5D (EQ-5D) summary scores and by the Diabetic Foot Ulcer-Short Form (DFS-SF) scores
Measured: Baseline, end of treatment, end of follow-up, and EQ5D only at 6 and 12 months
Cost effectiveness of HBOT: calculate the incremental cost per amputation avoided and the incremental cost per quality-adjusted life-year (QALY) gained
Measured: From Enrollment to 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Judy Dan Research and Treatment Centre Ontario Wound Care Inc, University Health Network, Toronto
- Responsible party
- Principal investigator, Ron Goeree, St. Joseph's Healthcare Hamilton
- Investigators
- Daria O'Reilly, PhD, Study chair, Programs for Assessment of Technology in Health Research InstituteLudwik Fedorko, MD, Principal investigator, Judy Dan Wound Care Centre/University Health NetworkRon Linden, MD, Principal investigator, Judy Dan Wound Care Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621608
- Sponsor's protocol ID
- HTA011-0708-01
- Acronym
- HBOT
- Status last verified
- May 2013
- First submitted
- 29 Jan 2008
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Reilly D, Linden R, Fedorko L, Tarride JE, Jones WG, Bowen JM, Goeree R. A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol. Trials. 2011 Mar 7;12:69. doi: 10.1186/1745-6215-12-69.
PubMed 21385365Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O'Reilly DJ. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care. 2016 Mar;39(3):392-9. doi: 10.2337/dc15-2001. Epub 2016 Jan 6.
PubMed 26740639
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Controlled Clinical Trial Comparing Standard Wound Care With Adjunctive Hyperbaric Oxygen Therapy (HBOT) to Standard Wound Care Only for the Treatment of Chronic, Non-healing Ulcers of the Lower Limb in Patients With Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00621608
- Acronym / sponsor ID
- HBOT / HTA011-0708-01
- Keywords
- Chronic ulcers, Diabetes, Hyperbaric Oxygen Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Judy Dan Research and Treatment Centre Ontario Wound Care Inc, University Health Network, Toronto
- Study start
- Apr 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Feb 2008 (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 determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs.
Detailed description
People with diabetes mellitus and non-healing ulcers of the lower limb are at higher risk of amputation. Current standard care for foot ulcers includes maintaining optimal blood glucose levels, use of debridement, antibacterials, dressings, antibiotics for infection; adequate nutrition; pressure relief and amputation. There has been an increased interest in the use of hyperbaric oxygen therapy (HBOT) as an adjunctive treatment for diabetic ulcers. HBOT is an established technology which currently is an accepted treatment of chronic diabetic ulcers in Ontario and physicians who provide this service are reimbursed under the current Ontario Health Insurance Plan (OHIP). However there are only a few facilities that can provide this service. In addition, results of published HBOT studies are inconsistent. The current study will provide quality efficacy data on the use of HBOT as an adjunctive therapy. As this study has been recommended by the Ontario Health Technology Advisory Committee (OHTAC), the results of the study will be used to make policy decisions regarding the funding and further utilization of HBOT therapy for people with diabetes mellitus with ulcers of the lower limb in the province. If the results are favorable towards HBOT in the treatment of diabetic ulcers, potential expansion and availability of this and other programs maybe be possible. A randomized placebo control trial evaluating HBOT, to the best of our knowledge has not been completed in this area and will provide much needed information to the scientific community.
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 |
|---|---|---|
| 1 | Experimental | Procedure: Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy |
| 2 | Sham comparator | Procedure: Placebo Hyperbaric Oxygen ChamberPlacebo Hyperbaric Oxygen Chamber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Type 1 or 2 Diabetes Mellitus
- Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks.
Key exclusion criteria (10 listed)
- Impending urgent amputation due to ongoing or exacerbated infection;
- Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed;
- Dialysis-dependent renal failure;
- Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity;
- History of chemotherapy with use of Bleomycin;
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 |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy (HBOT) will be provided 5 days per week for 6 weeks for a total of 30 treatments on average. Subjects will be placed into the hyperbaric chamber for approximately 90 minutes of HBOT at 2.4 ATA (partial pressure of oxygen = 1,800 mmHg) when inside the chamber. Subjects will receive dressing changes as required per standard of care. | Procedure or surgery | 1 |
| Placebo Hyperbaric Oxygen ChamberPatients will receive HBOT placebo 5 days per week for 6 weeks for a total of 30 treatments. Each patient will be placed into the hyperbaric chamber and will receive 90 minutes of room air while inside the chamber and the initial flow of air into the chamber will produce a small increase in pressure (0.3 ATA partial pressure of oxygen = 210 mmHg) which will then be released over a period of 10 minutes. Subjects will receive dressings changes as required per standard of care. | Procedure or surgery | 2 |
Primary outcome
Freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization.
Time frame: up to 12 weeks after randomization
6 secondary outcomes
Wound healing: difference in wound measurements (i.e. depth, length, width and extent of surface area); reduction in Wagner Classification Score; proportion of wound closed at 12 weeks of any time interval prior to end point; time to healing (days)
Time frame: up to 12 weeks after randomization
Effectiveness: maintenance on therapy (discontinuation rates); and secondary prevention interventions (confounding variables that may influence primary outcome such as diabetes control)
Time frame: up to 12 weeks after Randomziation
Safety: Major morbidity (infection requiring hospitalization, renal failure); wound interventions during study (debridement, surgery); Complications related to HBOT (seizure, pulmonary syndromes, vision disturbance; and all cause mortality
Time frame: From enrollment up to 1 year after randomization
Healthcare resource utilization: wound dressing materials; healthcare provider visits; inpatient hospital admissions; complex continuing care/rehabilitation; drug therapy; mobility assistive devices
Time frame: From enrollment to study up to 1 year after randomization
Quality of life: assessed by Standard Form 36 (SF-36) domain scores; EuroQoL 5D (EQ-5D) summary scores and by the Diabetic Foot Ulcer-Short Form (DFS-SF) scores
Time frame: Baseline, end of treatment, end of follow-up, and EQ5D only at 6 and 12 months
Cost effectiveness of HBOT: calculate the incremental cost per amputation avoided and the incremental cost per quality-adjusted life-year (QALY) gained
Time frame: From Enrollment to 1 year after randomization
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 9 May 2013.
- Background: PubMed 21385365O'Reilly D, Linden R, Fedorko L, Tarride JE, Jones WG, Bowen JM, Goeree R. A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol. Trials. 2011 Mar 7;12:69. doi: 10.1186/1745-6215-12-69.
- Derived from this study: PubMed 26740639Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O'Reilly DJ. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care. 2016 Mar;39(3):392-9. doi: 10.2337/dc15-2001. Epub 2016 Jan 6.
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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.
Daria O'Reilly, PhD study chair
Programs for Assessment of Technology in Health Research Institute
Ludwik Fedorko, MD principal investigator
Judy Dan Wound Care Centre/University Health Network
Ron Linden, MD principal investigator
Judy Dan Wound Care Centre/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric Oxygen Therapy in people with Diabetes Mellitus and Chronic Ulcers of the Lower Limb, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. (time frame: up to 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621608, which also lists 2 linked publications.
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 9 May 2013.