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

Abstract

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.

• Authors: Fang Wang, Nanbing Yuan, Yuzhen Wang, Chun Wang, Aihong Wang, Tingting Yu, Guanjian Liu, Zhangrong Xu, Xingwu Ran
• Journal: Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery (Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi) Vol. 26 Issue 8 Pg. 955-60 (Aug 2012) ISSN: 1002-1892 [Print] China
• PMID: 23012931 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents, Local
• Camphanes
• Hydrogel, Polyethylene Glycol Dimethacrylate
• Bismuth

Topics

• Administration, Topical
• Aged
• Anti-Infective Agents, Local (administration & dosage, therapeutic use)
• Bandages
• Bandages, Hydrocolloid
• Bismuth (administration & dosage, therapeutic use)
• Camphanes (administration & dosage, therapeutic use)
• Diabetic Foot (drug therapy)
• Female
• Humans
• Hydrogel, Polyethylene Glycol Dimethacrylate (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Randomized Controlled Trials as Topic
• Retrospective Studies
• Treatment Outcome
• Wound Healing