Pivotal Canadian study launched to treat complications of diabetes

    Oxygen therapy can reduce need for amputations

    TORONTO, June 4 /CNW/ - A landmark clinical trial has been launched in
Toronto to investigate the use of hyperbaric oxygen in treating a frequent
complication of diabetes - chronic non-healing wounds. The study is headed by
the Judy Dan Wound Care Centre in Toronto in collaboration with St. Joseph's
Healthcare in Hamilton and Programs for Assessment of Technology in Health
(PATH) Research Institute. Dr. Ron Linden, medical director, Ontario Wound
Care and Ludwik Fedorko, anesthesiologist, University Health Network, are
principal investigators. Funding has been provided by the Ontario Ministry of
Health & Long-Term Care following recommendations from the Ontario Health
Technology Advisory Committee.
    For the over 700,000 people in Ontario(1) diagnosed with diabetes,
between 10 to 15 per cent (70,000 to 105,000) will suffer with a foot
ulcer(1),(2). These ulcers can be difficult to treat, resulting in infections,
reduced patient quality of life, and possibly amputation. In Ontario, more
than 2,160 amputations as a result of severe diabetic foot ulcers occur on an
annual basis(3).
    Hyperbaric oxygen treatment (HBOT), an established medical technology,
has been shown to reduce amputations in diabetic patients by up to 75 per
cent(3). The Canadian prospective double-blind placebo-controlled study was
designed to investigate whether HBOT plus standard wound care in diabetic
patients is more effective than standard care alone in preventing the need for
amputation. The study will enroll 120 patients and estimated completion date
is mid 2010. All patients will receive standard care for diabetic foot ulcers
including diet control, maintenance of optimal blood glucose levels,
antibiotics and antibacterial dressings, and wound pressure relief.
    "Our experience with hyperbaric oxygen shows that it is effective in
healing difficult-to-treat diabetic ulcers which means reducing the need for
amputations," says Dr. Ron Linden, medical director of the Judy Dan Wound Care
Centre and Ontario Wound Care Inc. "This trial will allow us to investigate
the benefits of hyperbaric oxygen on a large scale, and provide additional
clinical evidence on treatment efficacy," he adds.
    Patients enrolled in the study will undergo treatment in state-of-the-art
individual compression chambers that resemble a space capsule. During the
90-minute treatment session, patients relax in a hyperbaric chamber breathing
100 per cent oxygen while the atmospheric pressure is increased two to three
times normal level to saturate the blood with oxygen. Delivering a high
concentration of oxygen to affected areas of the body supports fighting
infections, tissue growth and wound healing. The average course of treatment
runs for 30 sessions, five days per week. To track long-term outcomes,
participants will undergo a detailed follow-up for 18 weeks and a follow-up
phone call in six and 12 months.
    In 2003, less than 20 patients received HBOT therapy for diabetic wound
care, according to a report published by the Ontario Ministry of Health &
Long-Term Care(1). With the opening in 2007 of the Judy Dan Wound Care Centre,
a facility equipped with six individual hyperbaric chambers, up to
200 patients can now access treatment annually. The Judy Dan Wound Care
Centre, one of the largest in North America, was established through a
personal donation by Aubrey Dan, Toronto businessman, to purchase the
hyperbaric oxygen chambers.
    "Seeing a loved one lose a limb to diabetes can be devastating," comments
Aubrey Dan, president of the Dancap group of companies. "Dancap is pleased to
be associated with the healthcare team at the centre to help make a difference
for people living with diabetes. Wider access to this therapy is important,"
he adds. The Judy Dan Wound Care Centre is named for Dan's mother, a juvenile
diabetic from the age of 18. Judy Dan was a talented and versatile artist, who
before her death at the age of 61 had lost some of her toes and her left leg
through a series of amputations. The Judy Dan Wound Care Centre honours the
memory of this vibrant and compassionate woman who touched many who knew her.
    According to Dr. Ron Linden, the cost of providing HBOT treatment for a
diabetic patient to save a leg is approximately $3,000 to $4,000, with the
result that a patient can walk normally again. By contrast, the direct cost of
amputation, including hospitalization and rehabilitation is approximately
$70,000 and indirect costs including loss of independence, restricted
lifestyle, reduced productivity and long-term social services can be upwards
of $250,000 per patient. HBOT in addition to standard wound care for diabetic
patients could potentially save the Ontario healthcare system between
$5.8 million to $19.6 million annually(1).
    For more information regarding the clinical trial, contact the study
centre at 416-223-6600 or hbot@bellnet.ca.

    About Hyperbaric Oxygen Treatment (HBOT)

    HBOT is an established technology recognized in Canada and
internationally for the treatment of 13 medical conditions including healing
of chronic diabetic leg and foot wounds. The United States has over
400 hyperbaric facilities, primarily treating chronic wounds. In Canada, nine
facilities provide HBOT, with four located in Ontario (Toronto, Hamilton and
Ottawa). Provincial Ministries of Health recognize HBOT as an essential
medical treatment but do not fund costs of treatment.
    The use of HBOT for chronic wounds in Ontario has been reviewed and is
supported by the Ontario Medical Association, the College of Physicians &
Surgeons of Ontario and the Toronto District Health Commission.

    About Judy Dan Wound Care Centre/Ontario Wound Care Inc.

    Ontario Wound Care Inc. was incorporated as a non-profit registered
charity in 2005 in order to fund capital and operating costs of a centre that
would provide hyperbaric treatment and conduct research in wound care. Within
a year, funding required for capital costs of purchasing and installing
hyperbaric chambers, ancillary equipment and building a wound care facility
were successfully raised.
    In January 2007, Ontario Wound Care opened the Judy Dan Wound Care
Centre, located in the former Branson Hospital in Toronto. Using a
multi-disciplinary approach, patients receive first class care and consult
with specialists in wound care, hyperbaric medicine, internal medicine,
vascular and orthopedic surgery, and diabetic education.

    (1) Ontario Health Technology Advisory Committee. Hyperbaric oxygen
        therapy for non-healing ulcers in diabetes mellitus. August 11, 2005.
        (cited May 2008) Available from
    (2) Rakel A, Huti C, Ekoe JM. Canadian Diabetes Association Technical
        Review: The diabetic foot and hyperbaric oxygen therapy. Cnd J
        Diabetes 2006; 30 (4):411-421
    (3) Sosiak T, Evans W. Hyperbaric Medicine in Ontario. Ontario Medical
        Review 2005; 72 (5): 51-54

For further information:

For further information: For interviews, please contact: Yvonne
Burnside, (416) 322-3100, ygburnside@sympatico.ca

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