Working to Save Lives and Limbs - New Hope Emerges For Canadians with Diabetic Foot Ulcers



    TORONTO, June 26 /CNW/ - In an article in this month's issue of Expert
Opinion in Drug Delivery, (Informa UK Ltd) a group of US experts in the
management of diabetic foot ulcers (DFU) has identified Collatamp G (Theramed
Corp, Mississauga) as a promising and superior system for delivering high
concentrations of broad-spectrum antibiotic directly to the ulcer for patients
with infected diabetic foot ulcers.
    While Collatamp G is not yet available for use in the USA, it was
approved by Health Canada in 2007, and since 2008 has been used increasingly
in Canada for the treatment of serious Diabetic Ulcers. Dr. P. Mayer, Medical
Director of The Mayer Institute (www.themayerinstitute.ca) in Hamilton,
Ontario which specializes in advanced diabetic foot and wound care, performed
a trial of Collatamp G on 15 of his most serious cases.
    "We used Collatamp G on several chronic deep wounds associated with
osteomyelitis with excellent result. By providing a direct assault on the
infected bone, Collatamp G dramatically improved healing in chronic,
non-healing wounds and in at least 3 instances Collatamp G was key in helping
us prevent amputations."
    From his research and experience, Dr. Mayer concurs with the study's
conclusion and further states that "adoption of Collatamp G into the treatment
protocol for advanced diabetic foot ulcers, could dramatically reduce the
length of disability for these patients, and also reduce healthcare costs by
reducing the need for daily home-care visits to once or twice weekly."
    The Collatamp G product concept and technology is featured in an article
co-authored by David G Armstrong and Andrew Boulton et al in this month's
Expert Opinion on Drug Delivery ("The use of gentamicin-impregnated foam in
the management of diabetic foot infections: a promising delivery system?";
Catherine D Griffis, Stuart Metcalfe, Frank L Bowling, Andrew JM Boulton,
David G Armstrong, Expert Opinion on Drug Delivery, June 2009, Vol. 6, No. 6,
Pages 639-642).
    Improved and shortened time to healing in diabetic foot ulcers can have
significant implications to patients at risk of limb amputation, as well as to
the healthcare system as a whole. Chronic diabetic foot ulcers are a major
cause of home care visits and disability claims to health insurance providers.
Accelerating the healing process can reduce the overall burden on the
healthcare system by getting the patient back to work sooner.
    One of the major goals in management of Diabetic Foot Ulcer is "limb
salvage," that is, the prevention of limb amputation, which is both costly and
devastating to patients and their families. Because diabetic foot ulcers are
often complicated by infection, antibiotic therapy is an important component
in the management of the wound. Unfortunately traditional systemic antibiotics
do not result in sufficient concentrations at the target tissue due to a
number of factors, including the poor micro and macro circulation present in
people with diabetes, and the risk of toxicity associated with adequate doses.
    Because of these and other limitations of systemic antibiotics, the
authors of the paper note that "topical (or local) antimicrobial therapy in
the management of infected foot ulcers has been supported by several authors,"
whom they then cite. The authors also note that compared with other local
delivery systems, Collatamp G has been shown in European studies to be the
clinically and economically "superior delivery mechanism"

    About Collatamp G

    Collatamp G (http://collatampg.ca) is a biodegradable and fully
resorbable Gentamicin-Collagen Sponge. Upon application to a wound, the
product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic
(having a concentration-dependent mechanism of action), for local action. This
achieves a high concentration of drug at the target tissue, while maintaining
low systemic levels well below the toxicity threshold.
    Collatamp G was approved by Health Canada in 2007, and has since been
used in hundreds of Canadian surgical procedures and Diabetic Foot treatments
in over 40 Canadian Hospitals and Clinics.

    About Infected Diabetic Foot Ulcers

    According to the Centers for Disease Control and Prevention (CDC), the
estimated incidence of diabetes in the US exceeds 1.5 million new cases
annually, with an overall prevalence of 20.8 million people, or 7% of the US
population. By 2030, the International Diabetes Federation predicts that the
global prevalence of diabetes will almost double from 193 million people
(estimated in 2003) to 366 million.
    An estimated 15% of patients with diabetes will develop a lower extremity
ulcer during the course of their disease. According to a large prospective
study, approximately 7% of diabetic patients with foot ulcers will require an
amputation. Diabetes is responsible for 75% of the non-traumatic lower limb
amputations performed yearly in Canada. After a diabetic lower-limb
amputation, 50% of patients will have their other limb amputated within 2
years. The mortality rate after limb amputation approaches 80% - a death rate
second only to lung cancer (86%).
    The estimated cost of foot ulcer care in the US ranges from $4,595 per
ulcer episode to more than $28,000, for the 2 years post diagnosis. The total
annual cost of foot ulcer care in the US has been estimated to be as high as
$5 billion.
    Chronic ulcerations are often colonized or contaminated with bacterial
pathogens that can prevent ulcers from healing. Many such wounds become
clinically infected and require treatment with antibiotics. However, early
diagnosis of diabetic foot infections is a clinical challenge as typical signs
and symptoms of infection, such as pain, redness, or elevated circulating
inflammatory markers, can be absent in individuals with neuropathic or
neuroischaemic ulcers. Failure to diagnose and treat such infections can lead
rapidly to the infection spreading, with the possibility of tissue necrosis,
gangrene, osteomyelitis, and ultimately the prospect of a lower leg
amputation.
    Currently there are no antibiotics on the market specifically indicated
for the prevention of diabetic foot infections. There is also reluctance by
practitioners to use existing, systemically-acting antibiotics
prophylactically because of concerns with systemic side effects and fear of
propagating bacterial resistance with widespread use. Furthermore, diabetic
ulcers are often associated with vascular disease and restricted peripheral
blood flow, which may render systemically acting antibiotics less effective.
By achieving very high localized concentrations of antibiotic, Collatamp G is
designed to overcome these concerns.





For further information:

For further information: Stephen McElroy, Chief Commercial Officer,
Theramed Corporation, (www.theramed.com), (800) 305-4441,
smcelroy@theramed.com, www.collatampg.ca/journalists

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