Randomized double blind placebo ��? controlled trial of doxium in diabetic foot infection

Author(s): Fatemeh Ahmadi, Reza Shahrami, Shokrollah Salmanzadeh*

Abstract

Foot infection is the most common cause of extremity loss in diabetic patients. Doxium (calcium dobesilate) has antioxidant and anti-endothelin effects and improve blood supply. We assessed doxium as adjunctive drug for treatment of foot infection in diabetic patients. 64 diabetic patients with foot infection in grade 3 of Wagner classification were enrolled in a double blind placebo-controlled study. Patients were randomly assigned doxium therapy (trial n=32) or placebo (control n=32) for 30 days. Both groups received similar antibiotic and insulin treatment. Resolution time of infection, need to surgery, ankle/brachial index (ABI) and transcutaneous oxygen (TCO) were measured in two groups. Doxium therapy was associated with quicker resolution of infection and shorter time of antibiotic therapy (trial= 20.7 days vs. control= 25.4 days, P<0.01). On day 15th of treatment, 9.38% (3 patients) of trail and 34% (11 patients) of control (p < 0.02), needed surgical debridement, but there were no significant differences between two group at the end of study (day 30). Also we did not find, decreasing ABI over time is significant (0.10, P<0.001) but were similar among trail (from day 1 ABI= 0.96±0.04) and control groups (from day 1 ABI= 0.92± 0.04). Also study found TCO rose significantly in trail (from 73.8±11.3 to 79.50 mmHg) and control (from 66.60 to 70.40 mmHg) groups. Doxium can accelerate healing of diabetic foot infection in combination with antibiotic therapy. The mean time of infection resolution and antibiotic therapy decreased 4.7 days in doxium group compared with placebo group. Intervention could not raise the TCO pressure and also change in ABI in this study.

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