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.
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.
Collagenase can promote wound healing, and its effect depends on the degradation of necrotic tissue and the collagen degradation products produced by collagenase. The possible mechanisms include accelerating re-epithelialization, promoting the formation of granulation tissue and blood vessels, and regulating inflammatory response. At present, clinical studies have shown that collagenase combined with sharp debridement or negative pressure wound therapy can significantly promote the healing of diabetic foot ulcers, and its efficacy is similar to that of hydrocolloid occlusive dressing and silver-containing wound dressings. Collagenase can promote the repair of diabetic foot ulcers, but its effect is affected by many factors, and large-sample, good design, high quality and multi-center randomized controlled trials are still needed to explore its efficacy and appropriate use conditions. This paper expounds that collagenase is one of the options in the treatment of diabetic foot ulcers from mechanism and clinical effect.
Objective To assess the effectiveness of intensive versus routine education on diabetes mellitus for preventing diabetic foot ulcer. Methods We electronically searched CENTRAL (Issue 1, 2013), PubMed (1978-2013), EMbase (1978-2013), VIP (1989-2013) and WanFang Data (1980-2013), hand-searched correlated proceedings and retrieved the references of included studies, for the randomized controlled trials on intensive versus routine education on diabetes mellitus for preventing diabetic foot ulcer all over the world. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. Results Twelve trials involving 1 841 patients were finally included. The results of meta-analysis showed that: a) the incidence of diabetic foot ulcer in the intensive education group was lower than the routine group, with a significant difference (RR=0.51, 95%CI 0.30 to 0.84, P=0.008); b) two groups were alike in the amputation rate, with no significant difference (OR=0.54, 95%CI 0.17 to 1.67, P=0.28); and c) the score of knowledge on diabetes mellitus was higher in the intensive education group than in the routine education group, with a significant difference (MD=7.32, 95%CI 3.57 to 11.06, P=0.000 1). Conclusion Current evidence shows that: compared with routine education, intensive education could reduce the incidence of diabetic foot ulcer effectively. However, the above conclusion should be verified by conducting more high quality studies.
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.
Diabetic foot ulcer (DFU) is one of the most serious complications of diabetes mellitus. Considering complicated conditions, poor general condition, severe infection and poor outcomes as the feature characteristics of Chinese DFU patients, comprehensive and systematic evaluation, including general condition, region of the foot, and psychological status, is essential and fundamental for successful treatment. This commentary summarizes the evaluation contents in scientific and standardized diagnosis and treatment of diabetic foot ulcer, and looking forward to reducing morbidity, recurrence rate and mortality, and increasing limb salvage rate.
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.
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 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.
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.