Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by St. Joseph's Healthcare, June 2008
Sponsors and Collaborators: St. Joseph's Healthcare
Judy Dan Wound Care Centre, North York
University Health Network, Toronto
Information provided by: St. Joseph's Healthcare
ClinicalTrials.gov Identifier: NCT00621608
Purpose
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.
Condition Intervention Phase
Diabetes Mellitus Procedure: Hyperbaric Oxygen Therapy Phase IV
Chronic Ulcers of
the Lower Limb Procedure: Placebo Hyperbaric Oxygen Chamber
MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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.
Further study details as provided by St. Joseph's Healthcare:
Primary Outcome Measures:
* Freedom from having or meeting the criteria for major amputation determined by vascular surgeon or one of: persistent deep infection [ Time Frame: up to 18 weeks after randomization ] [ Designated as safety issue: No ]
* Risk of severe systemic infection related to wound; inability to bear weight on limb; pain causing significant disability [ Time Frame: up to 18 weeks after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
* Wound healing; effectiveness; safety; healthcare resource utilization; quality of life; cost effectiveness [ Time Frame: up to 18 weeks after randomization ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 118
Study Start Date: April 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Procedure: Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy 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.
2: Sham Comparator
Placebo Hyperbaric Oxygen Chamber Procedure: Placebo Hyperbaric Oxygen
Chamber
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.
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.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621608
Contacts
Contact: Wilhelmine Jones, Reg. Nurse 1-416-223-6600 willie.jones@uhn.on.ca
Contact: Ron Linden, MD 1-416-223-6600
Locations
Canada, Ontario
Judy Dan Wound Care Centre/University Health Network Recruiting
Toronto, Ontario, Canada, M2R 1N5
Principal Investigator: Ron Linden, MD
Principal Investigator: Ludwik Federko, MD
Sponsors and Collaborators
St. Joseph's Healthcare
Judy Dan Wound Care Centre, North York
University Health Network, Toronto
Investigators
Study Chair: Daria O'Reilly, PhD Programs for Assessment of Technology in Health Research Institute
Principal Investigator: Ludwik Fedorko, MD Judy Dan Wound Care Centre/University Health Network
Principal Investigator: Ron Linden, MD Judy Dan Wound Care Centre/University Health Network
More Information
Responsible Party: Programs for Assessment of Technology in Health Research Institute ( Ron Goeree, Director )
Study ID Numbers: HTA011-0708-01
First Received: January 29, 2008
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00621608
Health Authority: Canada: Health Canada
Keywords provided by St. Joseph's Healthcare:
Chronic ulcers
Diabetes
Hyperbaric Oxygen Therapy
Study placed in the following topic categories:
Metabolic Diseases
Ulcer
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Additional relevant MeSH terms:
Pathologic Processes
ClinicalTrials.gov processed this record on December 17, 2008
