Effect of dalteparin on healing of chronic foot ulcers in diabetic patients with peripheral arterial occlusive disease: a prospective, randomized, double-blind, placebo-controlled study.
OBJECTIVE
Chronic foot ulcers are a common, severe, and expensive complication threatening life and limb in patients with diabetes. The aim of the present study was to investigate the effect of dalteparin on ulcer outcome in patients with diabetes, peripheral arterial occlusive disease, and chronic foot ulcers.


METHODS
A total of 87 patients were investigated in a prospective, randomized, double-blind, placebo-controlled trial. Participants were randomized to treatment with subcutaneous injection of 5000 units dalteparin (Fragmin, Pharmacia Corporation; n = 44) or an equivalent volume of physiological saline (n = 43) once daily until ulcer healing or for a maximum of 6 months. Ulcer outcome was investigated by evaluating the number of patients 1). who healed with intact skin; 2). in whom the study ulcer was improved, unchanged, or impaired; or 3). who were amputated above or below the ankle level, as compared with control subjects.


RESULTS
Two patients, one on dalteparin and one on placebo, dropped out of the study. Ulcer outcome was significantly better (P = 0.042, two-sided chi(2) test for trend) in the dalteparin group (n = 43) compared with the placebo group (n = 42). A total of 29 patients healed with intact skin (n = 14) or decreased the ulcer area >or=50% (n = 15) in the dalteparin group compared with 20 (n = 9 and 11, respectively) in the placebo group. Five patients in each group showed impaired ulcer healing, i.e., the ulcer area increased >or=50%. Two patients in the dalteparin group were amputated compared with eight in the placebo group. Time to healing with intact skin was 17 +/- 8 weeks in the dalteparin group compared with 16 +/- 7 weeks in placebo group (NS).


CONCLUSIONS
The results of the present study indicate that dalteparin improves the outcome of chronic foot ulcers in diabetic patients with peripheral arterial occlusive disease.
Kalani
Majid
M
Department of Cardiology, Karolinska Hospital, Karolinska Institute, Stockholm, Sweden. majid.kalani@ks.se
Apelqvist
Jan
J
Blombäck
Margareta
M
Brismar
Kerstin
K
Eliasson
Björn
B
Eriksson
Jan W
JW
Fagrell
Bengt
B
Hamsten
Anders
A
Torffvit
Ole
O
Jörneskog
Gun
G
D017668:Age of Onset; D000368:Aged; D000369:Aged, 80 and over; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D015992:Body Mass Index; D017985:Dalteparin / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1; D003924:Diabetes Mellitus, Type 2; D003925:Diabetic Angiopathies / Q000188:drug therapy*; D017719:Diabetic Foot / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D008297:Male; D018579:Patient Selection; D010919:Placebos; D014945:Wound Healing / Q000187:drug effects*
D005343:Fibrinolytic Agents; D010919:Placebos; D017985:Dalteparin