An open trial of calcium dobesilate in patients with venous ulcers and stasis dermatitis

Venous leg ulcers and associated stasis dermatitis are a major cause of morbidity, economic loss, and decreased quality of life in afflicted patients. Hence, there has been a renewal of interest in the medical management of varicose veins and ulcers. Calcium dobesilate, a capillotropic agent, has been found to be beneficial in the treatment of varicose veins.

This is an open pilot study of 25 patients (15 with venous ulcers with/without stasis dermatitis, 10 with stasis dermatitis only) who were given calcium dobesilate, 500 mg twice daily, for 8 weeks. The clinical parameters were graded (0-4; 0, absent; 1, mild; 2, moderate; 3, severe; 4, very severe) both before and after therapy, and included pain, itching, tiredness, heaviness, paresthesia, cramps, and leg swelling. Evaluation also included subjective changes in tenderness, oozing, and pigmentation, and measurement of the circumference of the leg for swelling and malleolar edema (measured in millimeters). The venous ulcer sizes were also recorded both before and after therapy. Color Doppler studies were performed to confirm the diagnosis of varicose veins, determine the competence of the valves, and to rule out deep vein thrombosis. Serum biochemistry, hemogram, and urinalysis were performed both before and after treatment. The results were analyzed statistically using the Wilcoxon rank sum test and Student's t-test.

A statistically significant improvement was observed post-therapeutically in the clinical parameters of pain, itching, tiredness, heaviness, and leg swelling. There was also a significant decrease in ulcer size. The serum biochemistry, hemogram, and urinalysis remained unaffected. Color Doppler studies before treatment revealed venous valvular incompetence in 20 patients. They were repeated in only 10 patients after treatment, four of whom showed improved valvular competence. Recurrence of venous ulcers was seen in five of 12 patients who were followed up after therapy. No significant side-effects were noted.

Calcium dobesilate is an effective adjuvant therapy, with an absence of significant side-effects, in patients with venous ulcers and stasis dermatitis. More double-blind trials are required in the future to substantiate and evaluate the role of the drug in these two indications.