ADA: Fragmin (Dalteparin) Injections Help Heal Diabetic Foot Ulcers
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ADA: Fragmin (Dalteparin) Injections Help Heal Diabetic Foot Ulcers

By Jill Stein
Special to DG News

SAN FRANCISCO, CA -- June 17, 2002 -- Treatment with Fragmin® (dalteparin) promotes healing of chronic foot ulcers in diabetic patients with peripheral arterial occlusive disease, investigators reported here this week at the 62nd Scientific Sessions of the American Diabetes Association (ADA).

Their results also show that the number of foot amputations required because of ulcers can be reduced by adding dalteparin to a multidisciplinary treatment regimen.

Dr. Majid Kalani, with the Karolinska Institute in Stockholm, Sweden, and associates tested the use of dalteparin, a low molecular weight heparin, for the healing of chronic foot ulcers in 85 diabetic patients (mostly older men) with peripheral arterial occlusive disease, defined as a toe/arm blood pressure index less than or equal to 0.6, and chronic foot ulcers.

The researchers stratified patients based on toe blood pressure and ulcer characteristics using the Wagner classification system and then randomized 43 patients to treatment with dalteparin in a subcutaneous injection of 5,000 U (2,5000 U/mL), and 42 patients to a subcutaneous injection of 0.2 ml physiological saline. They administered treatment once daily until the ulcer healed or for a maximum of six months, and evaluated the ulcer area monthly to determine healing.

The baseline characteristics of the two treatment groups were similar, and all the foot ulcers were neuroischemic. The time to healing with intact skin was also similar in the two groups. However, ulcer healing was significantly better in the dalteparin group than in the placebo group. Twenty- nine patients healed with intact skin or had a decrease in ulcer area of more than 50 percent in the dalteparin group, compared to 20 patients in the placebo group. There were four times more amputations in the placebo group than in the dalteparin group (eight amputations in the placebo group and two in the dalteparin group).

According to the investigators, dalteparin may help heal foot ulcers in diabetic patients because of its favorable effects on inflammation, coagulation, and fibrinolysis, all of which help improve microcirculation.

The study was sponsored by Pharmacia & Upjohn, manufacturers of Fragmin.

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