Objective To determine the effectiveness and safety of autologous platelet-rich gel in the management of diabetic foot ulcer. Methods We searched Cochrane Central Register of Controlled Trails (CENTRAL), MEDLINE or PubMed, EMbase, OVID Database, Chinese Biological Medicine Database (CBMDisc), CNKI, Chinese VIP Database and WANFANG Database. We also handsearched the bibliographies of retrieved articles and correlated proceedings. The systematic review was conducted using the method recommended by the Cochrane Collaboration. Results Four trials involving 216 patients were included. Meta-analyses showed (1) Diabetic foot ulcer healing rate: Autologous platelet-rich gel was superior to the standard care (Plt;0.000 01); (2) Diabetic foot ulcer reduction rate: Autologous platelet-rich gel was superior to the standard care (P=0.000 3); (3) Diabetic foot ulcer healing time: Autologous platelet-rich gel was superior to the standard care (Plt;0.000 01); (4) Complications: No patient in these trials had complications. Conclusions The limited current evidence shows that autologous platelet-rich gel is safe and effective in the short-term treatment for diabetic foot ulcer.
Diabetic foot ulcer is one of the severe chronic complications that lead to disability and death of diabetic patients. In order to solve this problem, adjuvant therapy studies of diabetic foot ulcers have increased in recent years. Extracorporeal shock wave therapy is a novel adjuvant therapy that has been approved by the US Food and Drug Administration for diabetic foot ulcers wounds. In this paper, the mechanisms of extracorporeal shock wave therapy for diabetic foot ulcers are described, including wound angiogenesis, wound tissue blood perfusion, nerve regeneration, granulation tissue proliferation, inflammatory response, anti-infection, migration and differentiation of mesenchymal stem cells and endothelial progenitor cells. This study aims to provide a theoretical basis for the clinical application of extracorporeal shock wave therapy in clinical treatment of diabetic foot ulcers.
Objective To systematically analyze the randomized controlled trials that compare tissue-engineered skin (TES) with conventional treatment for chronic diabetic foot ulcer (DFU) in terms of effectiveness and utilization.Methods We searched the electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, CBMWeb, CNKI, and VIP) in order to compare the efficiency and safety between TES and conventional treatment (CT) in the patients with DFU. In addition, we manually searched reference lists from original studies and review articles.Results Seven trials were included, which were all randomized controlled trials and had a duration of DFU over 6 weeks. There were 880 participants that met inclusion criteria in all studies, and all patients underwent pre-treatment procedures and were treated by TES (human skin equivalents, living skin equivalents or bioengineered skin, such as Graftskin, Dermagraft and Graftjacket) for 12 weeks. All trials had two groups: the treatment group and the control group, but the two trials divided the treatment groups into 3 different dosages and 2 different ulcer allocation subgroups, respectively. Meta-analysis results showed significant differences in the rate of complete wound closure (Plt;0.0001, 95%CI 0.08 to 0.20) and in the occurrence of complications and severe adverse events (P=0.008, 95%CI – 0.06 to – 0.01) between TES treated patients and conventionally treated patients. Conclusion The review shows TES improves completed closure of DFU compared with CT, and it is more effective in reducing side effects.
Objective To investigate the effects of autologous platelet-rich gel (APG) combined with intelligent trauma negative-pressure comprehensive therapeutic instrument on patients with refractory diabetic foot ulcer (DFU). Methods A total of 80 patients with refractory DFU treated in the hospital from January 2015 to January 2017 were divided into the trial group (n=40) and the control group (n=40) by the random number table method. The patients in the two groups were given routine treatment, and on the basis, the patients in the control group were treated with the intelligent trauma negative-pressure comprehensive therapeutic instrument while the ones in the trial group were treated with APG combined with intelligent trauma negative-pressure therapeutic instrument alternately. All patients were observed for 12 weeks. The cure rates, healing time and changes of wound volumes in the two groups before treatment and at 2, 4, 8, and 12 weeks after treatment were recorded. Results The total effective rate of treatment in the trial group was higher than that in the control group (87.5% vs. 67.5%, P<0.05). The wound volumes in the two groups at 4, 8 and 12 weeks after treatment were smaller than those before treatment and at 2 weeks after treatment (P<0.05). The wound volumes in the trial group at 4, 8 and 12 weeks after treatment were significantly smaller than those in the control group (P<0.05). The healing times of Wagner Ⅱ and Ⅲ DFU in the trial group were significantly shorter than those in the control group [(24.71±4.29)vs. (33.84±6.09) days, P<0.05; (33.04±5.97)vs. (45.29±7.05) days, P<0.05]. Conclusion Alternate treatment with APG combined with intelligent trauma negative-pressure comprehensive therapeutic instrument for refractory DFU can promote wound healing, shorten wound healing time, and improve the clinical efficacy.
Objective To systematically review the efficacy of oxygen therapy for diabetic foot ulcers (DFUs). MethodsThe PubMed, Embase, Cochrane Library, CNKI, WanFang Data, and VIP databases were electronically searched to collect randomized controlled trials (RCT) on the efficacy of different oxygen therapies for DFUs from inception to April 1, 2024. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Statistical analysis was performed using R software, and GraphPad Prism was used for graphical representations. ResultsA total of 61 RCTs involving 4 306 DFUs cases were included in the analysis. The oxygen therapies examined primarily included hyperbaric oxygen, topical oxygen, and ozone therapy. The surface under the cumulative ranking curve (SUCRA) indicated that hyperbaric oxygen therapy ranked highest for healing rate, area reduction rate, and healing time (SUCRA values were 0.957, 0.868, and 0.869, respectively). However, hyperbaric oxygen therapy also ranked higher for amputation rate and adverse events (SUCRA values were 0.616 and 0.718, respectively). Further subgroup analysis revealed that hyperbaric oxygen therapy maintained the highest ranking in area reduction rate across subgroups defined by publication language and treatment duration. ConclusionHyperbaric oxygen therapy has advantages in terms of healing rate, area reduction rate, and healing time for DFUs, but it is also associated with higher amputation rates and adverse events. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
ObjectiveTo observe the effect of silver dressings on treating diabetic foot ulcer infection. MethodsA total of 105 patients with diabetic foot ulcers treated from May 2012 to April 2014 were randomly divided into two groups:group A and B. Patients in group A were treated with imported silver ion alginate dressing, while group B was treated with domestic nanometer silver dressing. All patients were given basic treatment, and the effect of silver dressing was evaluated by observing bacterial clearance rate and wound healing score. ResultsThere were significant improvement in bacterial clearance rate and wound healing score in both two groups after treatment. The bacterial clearance rate was similar between the two groups (P>0.05). However, the descending trend of wound healing score in group A was significantly more obvious than group B (P<0.01). ConclusionBoth two silver dressings are effective in the treatment of diabetic foot ulcer infection, but the effectiveness of silver ion alginate dressing is superior. Bacterial clearance rate and wound healing score are objective and applicable index to evaluate the treatment effects of silver dressing.
ObjectiveTo systematically evaluate the potential effectiveness of JinHuang powder in the treatment of diabetic foot ulcers (DFUs). MethodsDatabases including PubMed, The Cochrane Library, Web of Science, CBM, WanFang data, VIP and CNKI were electronically searched from their inception to December 2013, to identify randomized controlled trials (RCTs) about JinHuang powder for DFUs. Two reviewers screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies, and then meta-analysis was performed by using RevMan 5.1 software. ResultsA total of 3 RCTs involving 198 patients were included. The results of meta-analysis showed that:the JinHuang powder group were superior to the control group in total effective rate (RR=1.25, 95%CI 1.10 to 1.41, P=0.00) and the wound healing time (SMD=-3.32, 95%CI -5.69 to -0.96, P=0.00). ConclusionCurrent evidence suggests that the JinHuang powder is an effective therapeutic method for DFUs. Because of the limitations of quantity and quality of the eligible studies, large sample size studies are needed to validate the conclusion.
ObjectiveTo investigate the epidemiological characteristics and predisposing causes of diabetic foot ulcer (DFU) in the hospitalized patients with diabetic foot disease (DFD).MethodsThe clinical data of patients with DFD admitted to West China Hospital of Sichuan University between January 1st, 2012 and December 31st, 2018 were collected through the electronic medical record system. The demographic characteristics, blood glucose control status, and the predisposing causes of DFU were analyzed.ResultsA total of 1 022 DFD inpatients with an average age of (65.5±11.9) years old were included in this study, including 679 males and 343 females; 59.4% (513/864) of the patients had a college degree or above, but the patients with more severe DFD had lower educational level (χ2trend=19.554, P<0.001). The average time from diagnosis of diabetes mellitus to occurrence of DFD was (10.6±7.1) years, and 42.4% (433/1 022) of the patients had diabetes for over 10 years. Among the patients, 82.3% (841/1 022) treated diabetes irregularly, 56.2% (555/987) never monitored blood glucose, 51.2% (523/1 022) had a history of foot ulcers, and 8.6% (88/1 022) had a history of lower extremity or toe amputation. The average fasting blood glucose and hemoglobin A1c were (8.6±3.8) mmol/L and (8.2±2.1)%, respectively. There were 52.2% (525/1 006) and 94.4% (958/1 015) of the DFD patients companied with peripheral arterial disease and neuropathy, respectively. DFUs were mainly single (52.7%, 447/849) and neuro-ischemic ulcers (53.0%, 389/734). The main predisposing causes were physical causes (21.6%, 180/834) and trauma (19.2%, 160/834).ConclusionsThe patients with DFD have the characteristics of old age, long course of diabetes, irregular treatment of diabetes and poor control of blood glucose, combined with neurovascular diseases, and high recurrence rate of foot ulcer. Therefore, diabetes education, early screening of foot risk factors, and early intervention should be strengthened to prevent the occurrence and recurrence of DFU.
ObjectiveTo systematically review the clinical efficacy and safety of hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. MethodsSuch databases as The Cochrane Library (Issue 1, 2014), PubMed, EMbase, CBM, VIP, CNKI and WanFang Data were searched up to January 2014 for randomized controlled trials (RCTs) about hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsFourteen RCTs involving 910 patients were included. The results of meta-analysis showed that, hyperbaric oxygen therapy combined with routine therapy was superior to routine therapy alone regarding ulcer healing rates (RR=2.16, 95%CI 1.43 to 3.26, P=0.000 3), incidence of major amputation (RR=0.20, 95%CI 0.10 to 0.38, P < 0.000 01), reduction of ulcer area (MD=1.73, 95%CI 1.34 to 2.11, P < 0.000 01), and improvement of transcutaneous oxygen tension (MD=14.75, 95%CI 2.01 to 27.48, P=0.02). However, no significant difference was found between the two group in minor amputation rates (RR=0.70, 95%CI 0.24 to 2.11, P=0.53). In addition, neither relevant serious adverse reaction nor complications were reported when using hyperbaric oxygen therapy as adjunctive treatment. ConclusionCurrent evidence shows that hyperbaric oxygen therapy as adjunctive treatment could improve ulcer healing and reduce incidence of major amputation.
Objective To evaluate the efficacy and safety of Bismuth Subgallate/Borneol (SuileTM) (BSB) dressing in the treatment of diabetic foot ulcers. Method s A two-center, randomized controlled parallel-group comparison study was conducted. Between September 2005 and November 2006, 35 patients with nonhealing diabetic foot ulcer (Wagner 2-3 grade) were recruited and divided randomly into the test group (BSB group, n=25) and control group (IG group, n=10). There was no significant difference in general data between 2 groups (P gt; 0.05). Based on the comprehensive therapy of diabetic foot, ulcers were topically treated by SuileTM dressing and Intrasite gel in the BSB group and IG group, respectively. The ulcer area was measured once a week. Ulcer bleeding was observed and acceptance of the dressing was inquired each week. Results Of the patients, 22 patients in the BSB group and 8 in the IG group completed the clinical trial. Intention to treat (ITT) analysis indicated that the results were excellent in 19 (76%) cases, good in 3 cases (12%), fair in 1 case (4%), and poor in 2 cases (8%) in the BSB group. In the IG group, the results were excellent in 8 cases (80%) cases, fair in 1 case (10%), and poor in 1 case (10%). Per-protocol (PP) analysis showed that the results were excellent in 19 cases (86%) and good in 3 cases (14%) in the BSB group, and were excellent in 8 cases (100%) in the IG group. The results of ITT and PP analysis all showed no significant difference between 2 groups (P gt; 0.05). The change trend of ulcer areas in the BSB group was similar to that in the IG group. There was no significant difference in the hemostatic effect between 2 groups (P gt; 0.05) and the patients were more likely to accept BSB dressings. Conclusion BSB dressings is an effective, safe, and generally well-tolerated therapy dressing in the treatment of diabetic foot ulcers.