Abstract

Objective To evaluate the clinical effects and safety of a wound dressing containing bio-enzymes in the treatment of diabetic foot ulcer. Methods A total of 60 patients with diabetic foot ulcer were randomly assigned to either a trial group or a control group, in which a wound dressing containing bio-enzymes and a wound dressing containing normal saline were applied every day for 42 d, respectively. Patient′s age, body mass, fasting blood glucose, postprandial blood glucose, wound area, wound healing time, and treatment cost were compared between the two groups by Student′s t-test. Chi-square test and Fisher exact test were performed to compare the sex composition ratio, bacterial clearance rate, wound-surface exudation, and wound-edge response. Results The age, body mass, fasting blood glucose, and postprandial blood glucose were statistically comparable in the two groups. The bacterial clearance rates at 7 d and 14 d in the trial group were 84% and 96%, respectively, which were significantly higher than those in the control group (36% and 44%, respectively; P<0.05). At 14, 21, and 28 d, the scores of wound-surface exudation in the trial group were significantly better than those in the control group (P<0.05). At 7, 14, and 21 d, the scores of wound-edge response in the trial group were significantly better than those in the control group (P<0.05). At 1, 7, 14, 21, and 28 d, the wound areas of the trial group were significantly better than those of the control group (P<0.05). At 28 d, the wound healing rates of the trial group and the control group were 75.42% and 16.67%, respectively. The time to wound-surface healing was significantly shorter in the trial group than in the control group [(28.56±13.21) d vs (38.38±15.40) d, P<0.05)]. The average total cost of the trial group was significantly lower in the trial group (18 202.15±9189.92 yuan) than in the control group (26 249.86±11 458.13 yuan; P<0.05). No local or systemic adverse reactions occurred in either group. Conclusion The wound dressing containing bio-enzymes has good germicidal action, can reduce wound-edge response and wound-surface, and thus promotes wound-surface healing early, with high safety but low cost. Key words: Diabetic foot; Wound dressing containing bio-enzymes; Wound surface

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