| Objectives The experiment was designed to observe the effect of applying autologous fat grafting(AFG)in the healing of diabetic foot ulcers(DFUs).Another object is a further elucidation of the therapeutic potentials of AFG in DFUs by analyzing the conditions and mechanisms in wound healing.Methods A total of 60 patients with DFUs were selected from the Burn and Plastic Department at Tangshan Gongren Hospital.This study was a cluster-randomized trial with 4 parallel groups(Dressing Change Group,AFG Group,NPWT Group and AFG+NPWT Group),and all 60 patients were randomly divided into 4 groups,with 15 patients per group.There was no significant difference in baseline information.4 groups of patients finished different treatment and completed the 12-week post-treatment follow-up.A good standard of care was performed in all patients,including regular dress changing,supportive therapy,controlling blood glucose and the treatment of complications.Patients in the Dressing Change Group received standard care only during the study period.Patients in the AFG Group received debridement combined with AFG treatment;the patients in the NPWT Group received debridement combined with NPWT.Patients in the AFG+NPWT Group received debridement combined with AFG and NPWT.All patients were evaluated in the wound bed,and the wound was covered with autologous split-thickness skin at an appropriate time.The observation targets are as follows:granulation tissue score at the 7th day of treatment,the ulcer healing rate at the 14th day,21-day of continuous dynamic SINBAD scores,the recovery rate in each group at the 12th week,the incidence of adverse events,quality of life and occurrence rate of NPWT-related complications.Results 1 The result of granulation tissue score on the 7th day of treatment is showed as the name of group(count of 5 points/count of 4 points/count of 3 points/count of 2 points/count of 1 point/count of 0 points):Dressing Change Group(0/0/0/0/7/8),AFG Group(3/4/5/1/2/0),NPWT Group(2/1/7/2/1/2)and AFG+NPWT Group(8/65/1/1/0/0).There was a significant statistical difference between groups(P<0.001).Pairwise comparison between the four groups showed that Dressing Change Group vs AFG Group,Dressing Change Group vs NPWT Group,Dressing Change Group vs AFG+NPWT Group and NPWT Group vs AFG+NPWT Group were significantly different(P<0.05).It can be concluded that the quality of granulation tissue in the AFG+NPWT Group was better than that in Dressing Change Group and NPWT Group after 7 days of treatment,but there was no significant difference between AFG+NPWT Group and AFG Group.There was no significant difference in the granulation tissue between the NPWT Group and AFG Group,but they were both superior to the Dressing Change Group.2 The result of ulcer healing rate on the 14th day is showed as the name of group(x±s)%:Dressing Change Group(6.03±5.5)%,AFG Group(18.15±9.05)%,NPWT Group(16.81±5.4)%and AFG+NPWT Group(25.57±9.96)%.There was a significant statistical difference between groups(P<0.05).Pairwise comparison between the four groups showed that Dressing Change Group vs AFG Group,Dressing Change Group vs NPWT Group and Dressing Change Group vs AFG+NPWT Group were significantly different(P<0.05).It can be considered that,for the ulcer healing rate on the 14th day,there was no significant difference between AFG Group,NPWT Group and AFG+NPWT Group,but they were all higher than Dressing Change Group.3 The result of 21-day of continuous dynamic SINBAD scores showed a significant statistical difference between groups(P<0.05).Pairwise comparison between the four groups showed that the Dressing Change Group vs AFG+NPWT Group and AFG Group vs NPWT Group were significantly different(P<0.05).It can be considered that compared with the Dressing Change group and the NPWT group,the AFG+NPWT group could significantly reduce the severity of DFU,and the degree of this effect was gradually significant over time.4 The result of the recovery rate in each group at the 12th week is showed as follows:Dressing Change Group 20%,AFG Group 33.33%,NPWT Group 46.67%and AFG+NPWT Group 92.33%.There was a significant statistical difference between groups(P<0.001).Pairwise comparison between the four groups showed that Dressing Change Group vs AFG+NPWT Group,AFG Group vs NPWT Group and NPWT Group vs AFG+NPWT Group were significantly different(P<0.05).It can be considered that after 12 weeks of treatment,the healing rate was significantly higher in the AFG+NPWT Group than that in the other three groups.5 The result of the quality-of-life score is showed as the name of group(x±s):Dressing Change Group(44.93± 15.83),AFG Group(58.87±12.88),NPWT Group(50.73±12.28)and AFG+NPWT Group(63.33± 10.17).There was a significant statistical difference between groups(P<0.05).Pairwise comparison between the four groups showed that Dressing Change Group vs AFG Group,Dressing Change Group vs AFG+NPWT Group and NPWT Group vs AFG+NPWT Group were significantly different(P<0.05).It can be considered that,in terms of improving quality of life,AFG Group and AFG+NPWT Group were significantly better than Dressing Change Group and NPWT Group.6 The result of the incidence of adverse events is showed as follows:Dressing Change Group 53.33%,AFG Group 6.67%,NPWT Group 26.67%and AFG+NPWT Group no adverse events occurred.There was a significant statistical difference between groups(P<0.05).Pairwise comparison between the four groups showed that Dressing Change Group vs AFG Group,Dressing Change Group vs AFG+NPWT Group and NPWT Group vs AFG+NPWT Group were significantly different(P<0.05).It can be considered that the incidence of adverse events in the AFG+NPWT Group was significantly lower than that in the Dressing Change Group and NPWT Group.7 The result of the occurrence rate of NPWT-related complications was showed that,in the aspect of NPWT-related skin lesion and pain,there was a significant statistical difference between NPWT Group and AFG+NPWT Group.It can be considered that AFG could reduce the incidence of NPWT-related skin lesion and pain.Conclusions 1 Surgical intervention especially debridement is an effective way to promote the healing of refractory DFUs.2 The application of AFG combined with NPWT shows great advantages in reducing the severity of the wound,reducing the size of the wound and promoting wound epithelialization,and this advantage may gradually become significant with the advance of time.3 Adipose tissue may play an important role in the formation of granulation tissue.4 AFG in combination with NPWT can not only promote healing,reduce adverse events and improve the quality of the patients had better efficacy but also can reduce the NPWTrelated skin lesion and pain.The possible reason may be the adipose tissue could increase the thickness of local fragile skin,and bring excessive tension to against the local pressure caused by NPWT.The properties may also include anti-inflammatory and pain relief.Figure 4;Table17;Reference 193... |
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