| Objective:1.To investigate the effectiveness of collagen on the healing of diabetic foot ulcers;and to explore whether it can improve the healing rate,shorten the healing time compared with the standard treatment.2.To compare the difference in the depth or ulcer areas of diabetic foot ulcer with/without the use of collagen,and provide a new and effective treatment for the treatment of diabetic foot ulcers.Methods:1.One hundred and eighty DFU patients who in the Metabolic Hospital of Tianjin Medical University from November 2015 to October 2017(including Wagner grades 2 to 3 patients and patients in Wagner grade 4 with toe amputation)were admitted to this study.Each patient was given adequate treatment to improve metabolism(blood sugar,blood pressure,blood lipids,anti-platelet therapy),nutrition nerves,circulation improvement,anti-infection,wound treatment and so on.When the patient’s metabolism was stable,the infection was effectively controlled,and the wound bed was ready,then they were randomly divided into a collagen treatment group(90 cases)and a standard treatment group(90 cases).The standard treatment group was given daily wound dressings,if necessary,patients were given debridement and the collagen treatment group was given a medical collagen dressing on the basis of standard treatment.2.Each patient was tested by age,sex,duration of diabetes,duration of diabetic foot,FBG,HbA1c,liver function,renal function,ABI,TcPO2,and chronic complications of diabetes.3.Changes of granulation tissue growth in wounds of two groups was observed by the same clinician at 1st week,2nd week,4th week,and 8th week,in addition,the wound was photographed the area of the foot ulcer was measured with image processing software.The two groups of patients were observed and calculated the wound area,the healing rate,healing time and efficiency.In addition,the local adverse reactions and follow-up the prognosis of the two groups of patients were also observed.Results:1.Foot ulcer area size:1st week,foot ulcer area size(collagen group wound area 7.60±2.23cm~2,standard treatment group wound area 7.50±2.19cm~2)had no significant difference between the two groups(P>0.05).From the 2nd week,the wound area in the collagen treatment group was significantly reduced,compared with the standard treatment group and there was a statistical difference(P<0.05)(2nd week,the wound area of collagen group was 5.89±1.80cm~2,the wound area of standard treatment group was 6.70±1.78cm~2.In the fourth week,and 8th week,the wound area in the collagen group was respectively 4.60±1.90cm~2 and 3.60±1.85cm~2;5.85±1.76cm~2 and 4.96±1.91cm~2)In addition,in the collagen treatment group,there was a significant difference in the reduction of wound area at 2 weeks,4 weeks,and 8weeks(P<0.05).Similarly,the standard treatment group also obtained the above conclusion(P<0.05).2.Healing efficiency:No significant difference in healing efficiency between collagen treatment group and standard treatment group was observed at week 1 and 2(P>0.05)(1st week in collagen treatment group healing rate was 16.67%,standard treatment group healing rate was 17.78%;in the second week,the healing rate was 40.00%in the collagen treatment group,and 37.50%in the standard treatment group;).At 4weeks and 8 weeks,the total effective in rate the collagen treatment group was significantly higher than that in the standard treatment group(72.22%in the collagen treatment group in the 4th week and 44.46%in the standard treatment group;8th week in the collagen treatment group,the effective rate of healing was 88.89%,and the healing rate of the standard treatment group was 66.67%;),and it was statistically significant(P<0.05).3.Healing time:There was a significant difference in the total healing time between the two groups.The time of foot ulcer healing in the collagen treatment group was significantly shorter than that in the standard treatment group(78.00±5.43 days)(60.23±5.23 days)(P<0.05).In Wagner grade 2 patients,the healing time in the collagen treatment group was 18.23±5.56 days,which was no different from the standard treatment group healing time of 20.12±4.23 days(P>0.05);the healing time in the Wagner grade 3 collagen treatment group was 35.16±5.40.Days were significantly shorter than the standard treatment group(40.23±6.70 days)(P<0.05).In the Wagner class 4,the healing time of the collagen treatment group was 52.13±2.21days,which was significantly shorter than the standard treatment group healing time of 61.01±2.18 days.(P<0.05).4.Differences in the healing of different parts:there was a statistical significance in the healing of different parts(P<0.05).In terms of wound healing efficiency,the effective rate of toe healing in the collagen treatment group was 60.00%,which was significantly lower than the healing efficiency of the other three parts(95.45%of the dorsal,96.42%of the plantar,95.00%of the heel)(P<0.05),but there was no significant difference in the efficiency of the dorsal,plantar,and heel healing.There was no significant difference between the ulcer healing of different parts of the standard treatment group(toes 64.28%the dorsal 60.00%,plantar 75.00%,heel68.18%)(P>0.05).In addition,the healing of foot ulcers at the same site in the two groups was compared as follows:for patients with toe ulcers,there was no significant difference in the healing between the two groups(P>0.05),but in the other three sites,the foot ulcer healing of patients in the collagen treatment group was observed.The situation was significantly better than the standard treatment group(P<0.05).5.The occurrence of adverse events:In the course of treatment,whether in the collagen treatment group or the standard treatment group,there were a small number of localized patients with burning sensation,fever,irritation,irritation,rash,and other adverse reactions,but there was no significant difference(the incidence of adverse reactions in the collagen treatment group was 18.89%,and the incidence of adverse reactions in the standard treatment group was 21.11%)(P>0.05).Conclusions:1.After the wound of diabetic foot treating with medical collagen dressing,the wound area was significantly reduced compared with the standard treatment group,the total effective rate was higher and the total healing time was shorter.2.For Wagner grade 2 patients,the healing effect of collagen is equivalent to standard treatment,Wagner 3 and Wagner 4 patients,collagen recovery effect is better than standard treatment.3.After the application of collagen dressing filling treatment,different parts of the foot ulcer can be promoted wound healing.However,the healing condition was not the same,and the use of the collagen group on the dorsal,plantar and heel points was better than the standard treatment. |
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