Status:
COMPLETED
Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
Judy Dan Research and Treatment Centre Ontario Wound Care Inc
University Health Network, Toronto
Conditions:
Diabetes Mellitus
Chronic Ulcers of the Lower Limb
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00621608
Start Date
April 1 2008
End Date
April 1 2013
Last Update
May 9 2013
Active Locations (1)
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1
Judy Dan Wound Care Centre/University Health Network
Toronto, Ontario, Canada, M2R 1N5