Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers — HBOT  

Diabetes Mellitus Clinical Trial

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.

Status Completed

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Ulcers of the Lower Limb
• Diabetes Mellitus
• Ulcer

• NCT number: NCT00621608
• Study type: Interventional
• Source: St. Joseph's Healthcare Hamilton
• Status: Completed
• Phase: Phase 4
• Start date: April 2008
• Completion date: April 2013