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Comparison of negative pressure wound therapy and moist wound care in patients with diabetic foot ulcers: A protocol for systematic review and meta-analysis of randomized controlled trials

ABSTRACT:

Background:

This study conducted a meta-analysis to compare the effectiveness and safety of the negative pressure wound therapy (NPWT) with the moist wound care (MWC) in the treatment of diabetic foot ulcers (DFUs).

Methods:

The PubMed, EMBASE, and CENTRAL were searched by 2 of the authors, to identify randomized controlled trials comparing the clinical outcomes of patients treated with NPWT versus MWC for DFUs. Meta-analyses were performed for several outcomes, including wound healing results, amputation or resection incidence, and risk of adverse events, utilizing the “meta” package of R language version 4.0.3.

Results:

A total of 10 trials (619 patients in NPWT group and 625 in MWC group) and 8 trials were included for the qualitative and quantitative syntheses, respectively. As a result, significantly lower risk of non-closure of the wound (risk ratio [RR] = 0.74, 95% confidence interval [CI]: 0.63–0.87; P = .001), lower average wound area (standard mean difference = −0.80, 95% CI: −1.54 to −0.06; P = .034), more wound area decrease (standard mean difference = 0.81, 95% CI: 0.36–1.26; P = .001), increased appearance rate of granulation tissue (RR = 1.61, 95% CI: 1.07–2.41; P-0.021), and lower risk of amputation or resection (RR = 0.70, 95% CI: 0.50–0.99; P = .045), were demonstrated for the NPWT group when compared to MWC group. However, no statistically significant difference was found for the disappearance rate of wound discharge at 8 weeks, the rate of blood culture positivity, VAS-pain score, and the overall frequency of adverse events between the 2 treatment groups (P = .05).

Conclusion:

NPWT could accelerate process of the wound healing, and decrease the risk of post-treatment amputation or resection, without any additional frequency of adverse events, when compared with MWC, in patients with DFUs.

SUBMITTER: Wang N

PROVIDER: S-EPMC9351851 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Project description:Label‑free quantitative mass spectrometry was used to analyze the differences in the granulation tissue protein expression profiles of patients with diabetic foot ulcers (DFUs) before and after negative‑pressure wound therapy (NPWT) to understand how NPWT promotes the healing of diabetic foot wounds. A total of three patients with DFUs hospitalized for Wagner grade 3 were enrolled. The patients received NPWT for one week. The granulation tissue samples of the patients prior to and following NPWT for one week were collected. The protein expression profiles were analyzed with label‑free quantitative mass spectrometry and the differentially expressed proteins (DEPs) in the DFU patients prior to and following NPWT for one week were identified. Gene Ontology and Kyoto Encyclopedia of Genes and Genomes analyses were conducted to annotate the DEPs and DEP‑associated signaling pathways. Western blotting and ELISA were performed to validate the results. By comparing the differences in the protein profiles of granulation tissue samples prior to and following NPWT for one week, 36 proteins with significant differences were identified (P<0.05); 33 of these proteins were upregulated and three proteins were downregulated. NPWT altered proteins mainly associated with antioxidation and detoxification, the cytoskeleton, regulation of the inflammatory response, complement and coagulation cascades and lipid metabolism. The functional validation of the DEPs demonstrated that the levels of cathepsin S in peripheral blood and granulation tissue were significantly lower than those prior to NPWT (P<0.05), while the levels of protein S isoform 1, inter α‑trypsin inhibitor heavy chain H4 and peroxiredoxin‑2 in peripheral blood and granulation tissue were significantly higher than those prior to NPWT (P<0.05). The present study identified multiple novel proteins altered by NPWT and laid a foundation for further studies investigating the mechanism of action of NPWT.

Project description:ObjectivesThe aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.DesignIn this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.SettingThis German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.Participants368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.InterventionsNPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.Primary and secondary outcome measuresPrimary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.ResultsIn the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.ConclusionsNPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.Trial registration numbersNCT01480362 and DRKS00003347.

Project description:Our study aims to investigate the effect of negative pressure wound therapy (NPWT) on microRNA-155 (miR-155) in the granulation tissue of patients suffering from diabetic foot ulcers (DFUs) and its correlation with wound healing. A total of sixty patients diagnosed with DFUs were randomly assigned to either the NPWT group (n = 40) or the Non-NPWT group (n = 20) in a 2:1 ratio. After debridement, the NPWT group received NPWT treatment for one week, while the Non-NPWT group underwent routine dressing therapy. The expression of miR-155 in DFU granulation tissues was evaluated by qRT-PCR before and after treatment for one week. Following termination, wound healing rates were assessed in the NPWT group, and the correlation between variations in miR-155 expression (ΔmiR-155) and wound healing was analyzed pre and post NPWT treatment. In vitro experiments were conducted to investigate the effects of negative pressure on variations of miR-155 expression, as well as proliferation, migration, and apoptosis in normal human dermal fibroblasts (NHDFs). The NPWT group showed a decrease in miR-155 expression in wound granulation tissue compared with pre-treatment [4.12 (1.22, 14.85) vs. 6.83 (2.15, 15.72), P < 0.05]. Conversely, there was no statistically significant difference in miR-155 expression in wound granulation tissue between pre-treatment and post-treatment in the Non-NPWT group (P > 0.05). However, analysis revealed a positive correlation between ΔmiR-155 and wound healing rate after 4 weeks in the NPWT group (χ2 = 4.829, P = 0.028). The in vitro experiments showed a significant decrease in miR-155 expression in NHDFs under negative pressure measured at -125 mmHg (P < 0.05). This reduction in miR-155 expression, in turn, enhanced the proliferation and migration ability while decreasing the apoptosis rate of NHDFs by targeting the upregulation of fibroblast growth factor 7 (FGF7) gene expression (P < 0.05). It is concluded that NPWT promotes DFU healing by reducing the expression of miR-155 in granulation tissue and the efficacy of NPWT correlated with altered miR-155 expression in wound tissue.

Project description:BackgroundIn August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment.Methods/designThe DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs.DiscussionThe DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems.Trial registrationClinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Project description:Various types of flaps are considered as reconstructive options for patients with diabetic foot ulcer. However, flap reconstruction for diabetic foot ulcer treatment is particularly challenging because of the relatively limited collateral perfusion in the distal lower extremity. This study evaluated the efficacy and safety of a novel postoperative monitoring procedure implemented in conjunction with negative pressure wound therapy immediately after flap operations for treating diabetic foot. A retrospective analysis was performed on diabetic foot patients who underwent free flaps and perforator flaps from March 2019 through August 2021. The surgical outcomes of interest were the rates of survival and complications. On the third postoperative day, patients underwent computed tomography angiography to check for pedicle compression or fluid collection in the sub-flap plane. Monitoring time, as well as comparisons between NPWT and conventional methods, were analyzed. Statistical analysis was performed between the two groups. This study included 26 patients. Among patients, the negative pressure wound Therapy treated group included 14 flaps and the conventional monitoring group included 12 flaps. There was no significant intergroup difference in flap survival rate (p = 0.83). In addition, there was no significant intergroup difference in the diameters of perforators or anastomosed vessels before and after negative pressure wound therapy (p = 0.97). Compared with conventional monitoring, flap monitoring with incisional negative pressure wound therapy was associated with a significantly lower mean monitoring time per flap up to postoperative day 5. Although conventional monitoring is widely recommended, especially for diabetic foot ulcer management, the novel incisional negative pressure wound therapy investigated in this study enabled effortless serial flap monitoring without increasing complication risks. The novel flap monitoring technique is efficient and safe for diabetic foot patients and is a promising candidate for future recognition as the gold standard for flap monitoring.