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OBJECTIVE: To evaluate healing of chronic diabetic foot ulcers (DFUs) with use of dehydrated human amniotic membrane (dHAM) in patients failing under standard of care treatment. METHOD: The study population was identified from patients with chronic DFUs enrolled in a randomised trial comparing standard care with standard care with the addition of dHAM. The present study included patients that failed to heal (defined as < 50% decrease in wound size after 6 weeks, or not completely healed by 12 weeks of treatment) with standard care. One week after withdrawal from the randomised trial, these patients were offered treatment with standard care and bi-weekly application of dHAM. Subsequent evaluation of clinical records was made with IRB approval and patient consent. Each patient was used as their own control to compare wound size reduction between treatment periods, and healing rates within the 12-week dHAM treatment period. RESULTS: Eleven patients were included in the study. Mean wound chronicity was 21.1 +/- 12.4 weeks (range 11-54 weeks) and mean wound size was 4.7 +/- 5.0cm2, at baseline. Complete healing was achieved in 55% by 4 weeks, 64% by 6 weeks and 91% by 12 weeks with bi-weekly dHAM application. Mean weeks to complete healing was 4.2 +/- 3.1 weeks for the 10 patients healed. After 4 weeks of standard care, wounds had decreased in size an average of 26.8 +/- 45.3% versus 87.6 +/- 16.0% after 4 weeks of dHAM treatment (two applications; p < 0.001). CONCLUSION: This study provides evidence that the incorporation of dHAM into standard of care for patients with chronic DFUs can be beneficial. The results suggest that dHAM is a viable option for the treatment of recalcitrant DFUs.
Charles M. Zelen (Mon,) studied this question.