| Objective:The aim of this paper is to observe the effect of basic fibroblast growth factor(bFGF)combined with foam dressing on diabetic foot ulcer.The effects of b FGF combined with foam dressings or foam dressings alone on the rate of ulcer area reduction,ulcer healing rate,and Realization rate which ulcer area reduction of 75% or greater than 75%,ulcer dynamic score,and adverse event were compared,which provides reference ideas for the clinical prevention and treatment of diabetic foot ulcer.Methods:1.Intervention method: A total of 32 patients who met the inclusion criteria and exclusion criteria were randomized assigned into the experimental and control groups.The pre-control of blood sugar,the debridement,the anti-infection,and the wound bed were well prepared for all the subjects.Then,the experimental group used growth factor combined with foam dressings in the treatment of diabetic foot ulcers,while the control group used foam dressings alone.The changes in the ulcer area reduction and ulcer dynamic score for patients were compared on 0th day,7th day,14 th day,21 th day,28 th day,35 th day,42 th day,49 th day and 56 th day of the intervention.And at the end of the follow-up period,the wound healing rate,the area of ulcer decreased by 75% or more,and the adverse event were also analyzed.2.Statistical method: The dichotomous variables were described by frequency and rate.The chi-square test was used to compare the groups.The continuous variable that consistent with positive state distribution was described as the mean ± standard deviation.And do not comply with was described by median and quartile spacing.The data for the two groups was analyzed by using independent sample t test for statistical analysis,repeated measures variance analysis and kaplan-meier method.Results:1.A total of 36 patients were considered as the sample size based on the calculation.Two patients in the experimental group were withdrawn from the study because of the deterioration of the disease.And two patients in the control group were withdrawn from the study because of difficulty in dressing after discharge.Eventually intervention in 32 patients was completed.Two groups of patients in the demographic basic information,ulcer-related information,and metabolic index data had not statistically significant differences.2.Ulcer area reduction: There was no significant statistical difference in the ulcer area between the two groups on 0th day of the intervention.And there was no statistically significant in the ulcer area between the two groups on 7th day of the intervention(t=2.246,P>0.05).There was a statistically significant in the ulcer area reduction of ulcer on 14 th day,21 th day,28 th day,35 th day,42 th day,49 th day and 56 th day of the intervention(t=6.329,1.107,3.757,0.229,0.378,0.202,13.429,P<0.05).Further repeated measures analysis of variance showed that the rate of area reduction of two groups in using different interventions,time,between intervention and time were statistically significant difference(P<0.05).3.Wound healing rate: After 56 days of treatment,the wound healing rate of 16 patients in the control group and trial group were 43.75% and 75%(P=0.074),respectively.And there were no significant statistical difference.4.Realization rate which ulcer area reduction of 75% or greater than 75%: After 56 days of treatment,16 patients in the trial group had a rate of 93.75% which ulcer area reduction 75% or greater than 75%,while the control group had a rate of 62.5%(P=0.041).And there were a significant statistical difference.5.Ulcer dynamic score: There was no significant statistical difference in ulcer dynamic score between the two groups on 0th day of the intervention(t=0.625,P=0.000).And there was no statistically significant in ulcer dynamic score between the two groups on 7th day of the intervention(t=7.775,P=0.531).There was a statistically significant in the dynamic score of ulcer on 14 th day,21 th day,28 th day,35 th day,42 th day,49 th day and 56 th day of the intervention(t=0.047,0.047,0.041,0.045,0.029,0.034,0.036,P<0.05).6.Adverse event: There was no serious adverse event happened in this experiment.And there was no a statistical difference in the adverse event like infection,edema,bleeding,dermatitis between the two groups in the intervention process(P>0.05).Conclusions:1.bFGF combined with foam dressings and foam dressings alone both have good effect on the treatment of 1,2 and 3 diabetic foot ulcers.However,the group that combines bFGF with foam dressings is superior to the group with foam dressings alone in reducing the ulcer area,increasing realization rate which ulcer area reduction of 75% or greater than 75%,reducing the ulcer dynamic score.2.During the study period,there was no serious adverse event happened in patients who were used bFGF and foam dressings.Therefore,bFGF combined with foam dressings for the treatment of diabetic foot is safe. |
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