Comparison of a bioimplant dressing with a wet dressing for the treatment of diabetic foot ulcers: A randomized, controlled clinical trial.

BACKGROUND: The authors aimed to evaluate the efficacy of a bioimplant dressing in comparison with a wet dressing in patients with diabetic foot ulcers (DFUs).

MATERIALS AND METHODS: Fifty-seven patients with diabetes who had an ulcer of Wagner Grades 2-4 were included in this controlled clinical trial. The study was conducted in the outpatient diabetic foot clinic of Dr. Shariati Hospital, affiliated with the Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran, from November 2010 to March 2012. Fifty-seven cases of DFUs were equally and randomly divided into control and test groups. The bioimplant group received an amniotic membrane dressing while the control group was treated with a wet dressing. Both groups were evaluated once a week for 6 weeks for the degree of epithelialization and granulation tissue of the wound.

RESULTS: The complete healing rate (ie, wound closure) in the whole study population was 28.1% (control group, 16.7%; bioimplant group, 40.7%, P = 0.04). In 21 patients (77.77%) of the bioimplant group, granulation tissue was extended within the third visit. Amputation and hospitalization rates were higher in the control group compared to the bioimplant group; however, the difference was not statistically significant (relative risk [RR]: 1.11, 95% CI 0.91-1.34, P = 0.258; RR: 1.27, 95% CI 0.97-1.66, P = 0.076, respectively).

CONCLUSION: The bioimplant dressing was significantly superior to the wet dressing in prompting the complete healing of DFUs. Ease of use, absence of adverse effects, and a facilitated wound healing process are among properties of amniotic membrane that make it an appropriate dressing in the management of DFUs. Additional research will shed more light on the promising advantages of this material in healing DFUs.