Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers - Full Text View

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 Chronic Ulcers of the Lower Limb	Procedure: Hyperbaric Oxygen Therapy Procedure: Placebo Hyperbaric Oxygen Chamber	Phase IV

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, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. [ Time Frame: up to 12 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) [ Time Frame: up to 12 weeks after randomization ] [ Designated as safety issue: No ]
Effectiveness: maintenance on therapy (discontinuation rates); and secondary prevention interventions (confounding variables that may influence primary outcome such as diabetes control) [ Time Frame: up to 12 weeks after Randomziation ] [ Designated as safety issue: No ]
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 [ Time Frame: From enrollment up to 1 year after randomization ] [ Designated as safety issue: Yes ]
Healthcare resource utilization: wound dressing materials; healthcare provider visits; inpatient hospital admissions; complex continuing care/rehabilitation; drug therapy; mobility assistive devices [ Time Frame: From enrollment to study up to 1 year after randomization ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, end of treatment, end of follow-up, and EQ5D only at 6 and 12 months ] [ Designated as safety issue: No ]
Cost effectiveness of HBOT: calculate the incremental cost per amputation avoided and the incremental cost per quality-adjusted life-year (QALY) gained [ Time Frame: From Enrollment to 1 year after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	118
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hyperbaric Oxygen Therapy	Procedure: 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.

Arms

Assigned Interventions

1: Experimental

Hyperbaric Oxygen Therapy

Procedure: 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

No publications provided

Responsible Party:	Programs for Assessment of Technology in Health Research Institute ( Ron Goeree, Director )
Study ID Numbers:	HTA011-0708-01
Study First Received:	January 29, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00621608 History of Changes
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
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Pathologic Processes
Metabolic Diseases
Ulcer

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009