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.
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.
Condition:
Diabetes Mellitus
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
April 2008
Sponsor:
St. Joseph’s Healthcare Hamilton
For More Information:
https://clinicaltrials.gov/show/NCT00621608