Clinical trial NCT00621608: Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Chronic Ulcers of the Lower Limb
Keywords: Chronic ulcers
Diabetes
Hyperbaric Oxygen Therapy
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Judy Dan Research and Treatment Centre Ontario Wound Care Inc
name: University Health Network, Toronto
First posted: 2008-02-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization.
timeFrame: up to 12 weeks after randomization
Secondary outcomes:
measure: 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)
timeFrame: up to 12 weeks after randomization
measure: Effectiveness: maintenance on therapy (discontinuation rates); and secondary prevention interventions (confounding variables that may influence primary outcome such as diabetes control)
timeFrame: up to 12 weeks after Randomziation
measure: 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
timeFrame: From enrollment up to 1 year after randomization
measure: Healthcare resource utilization: wound dressing materials; healthcare provider visits; inpatient hospital admissions; complex continuing care/rehabilitation; drug therapy; mobility assistive devices
timeFrame: From enrollment to study up to 1 year after randomization
measure: 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
timeFrame: Baseline, end of treatment, end of follow-up, and EQ5D only at 6 and 12 months
measure: Cost effectiveness of HBOT: calculate the incremental cost per amputation avoided and the incremental cost per quality-adjusted life-year (QALY) gained
timeFrame: From Enrollment to 1 year after randomization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Judy Dan Wound Care Centre/University Health Network
state: Ontario
Study officials:
affiliation: Programs for Assessment of Technology in Health Research Institute
name: Daria O'Reilly, PhD
role: STUDY_CHAIR
affiliation: Judy Dan Wound Care Centre/University Health Network
name: Ludwik Fedorko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Judy Dan Wound Care Centre/University Health Network
name: Ron Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fedorko 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.