[Clinical study on topical bismuth subgallate/borneol (Suile) dressing for treatment of diabetic foot ulcers].

Objective: To evaluate the efficacy and safety of Bismuth Subgallate/Borneol (Suile) (BSB) dressing in the treatment of diabetic foot ulcers.

Methods: A two-center, randomized controlled parallel-group comparison study was conducted. Between September 2005 and November 2006, 35 patients with nonhealing diabetic foot ulcer (Wagner 2-3 grade) were recruited and divided randomly into the test group (BSB group, n = 25) and control group (IG group, n = 10). There was no significant difference in general data between 2 groups (P > 0.05). Based on the comprehensive therapy of diabetic foot, ulcers were topically treated by Suile dressing and Intrasite gel in the BSB group and IG group, respectively. The ulcer area was measured once a week. Ulcer bleeding was observed and acceptance of the dressing was inquired each week.

Results: Of the patients, 22 patients in the BSB group and 8 in the IG group completed the clinical trial. Intention to treat (ITT) analysis indicated that the results were excellent in 19 (76%) cases, good in 3 cases (12%), fair in 1 case (4%), and poor in 2 cases (8%) in the BSB group. In the IG group, the results were excellent in 8 cases (80%) cases, fair in 1 case (10%), and poor in 1 case (10%). Per-protocol (PP) analysis showed that the results were excellent in 19 cases (86%) and good in 3 cases (14%) in the BSB group, and were excellent in 8 cases (100%) in the IG group. The results of ITT and PP analysis all showed no significant difference between 2 groups (P > 0.05). The change trend of ulcer areas in the BSB group was similar to that in the IG group. There was no significant difference in the hemostatic effect between 2 groups (P > 0.05) and the patients were more likely to accept BSB dressings.

Conclusion: BSB dressings is an effective, safe, and generally well-tolerated therapy dressing in the treatment of diabetic foot ulcers.