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PloS One 2021Cardiac autonomic neuropathy is a common complication of type 2 diabetes mellitus (T2DM), that can be measured through heart rate variability (HRV)-known to be decreased... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cardiac autonomic neuropathy is a common complication of type 2 diabetes mellitus (T2DM), that can be measured through heart rate variability (HRV)-known to be decreased in T2DM. Physical exercise can improve HRV in healthy population, however results are under debate in T2DM. We conducted a systemic review and meta-analysis to assess the effects of physical exercise on HRV in T2DM patients.
METHOD
PubMed, Cochrane, Embase, and ScienceDirect databases were searched for all studies reporting HRV parameters in T2DM patients before and after exercise training, until September 20th 2020, without limitation to specific years. We conducted random-effects meta-analysis stratified by type of exercise for each of the HRV parameters: RR-intervals (or Normal to Normal intervals-NN), standard deviation of RR intervals (SDNN), percentage of adjacent NN intervals varying by more than 50 milliseconds (pNN50), root mean square of successive RR-intervals differences (RMSSD), total power, Low Frequency (LF), High Frequency (HF) and LF/HF ratio. Sensitivity analyses were computed on studies with the highest quality.
RESULTS
We included 21 studies (9 were randomized) for a total of 523 T2DM patients: 472 had an exercise training and 151 were controls (no exercise). Intervention was endurance (14 studies), resistance (2 studies), endurance combined with resistance (4 studies), and high intensity interval training (HIIT) (4 studies). After exercise training, all HRV parameters improved i.e. an increase in SDNN (effect size = 0.59, 95%CI 0.26 to 0.93), RMSSD (0.62, 0.28 to 0.95), pNN50 (0.62, 0.23 to 1.00), HF (0.58, -0.16 to 0.99), and a decrease in LF (-0.37, -0.69 to -0.05) and LF/HF (-0.52, -0.79 to -0.24). There were no changes in controls. Stratification by type of exercise showed an improvement in most HRV parameters (SDNN, RMSSD, pNN50, LF, HF, LF/HF) after endurance training, whereas mostly LF/HF was improved after both resistance training and HIIT. Supervised training improved most HRV parameters. Duration and frequency of training did not influence the benefits on HRV.
CONCLUSION
Exercise training improved HRV parameters in T2DM patients which may reflect an improvement in the activity of the autonomic nervous system. The level of proof is the highest for endurance training. Supervised training seemed beneficial.
Topics: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Endurance Training; Exercise; Female; Heart; Heart Rate; High-Intensity Interval Training; Humans; Male; Randomized Controlled Trials as Topic; Resistance Training
PubMed: 33999947
DOI: 10.1371/journal.pone.0251863 -
Diabetes, Obesity & Metabolism Jan 2023To estimate the long-term mortality and risk factors in patients with diabetic foot ulcer (DFU). (Meta-Analysis)
Meta-Analysis
AIM
To estimate the long-term mortality and risk factors in patients with diabetic foot ulcer (DFU).
METHODS
We systematically searched Medline (PubMed), Embase, Scopus, Web of Science, Cochrane Library, China Science and Technology Journal Database (CQVIP), China National Knowledge Infrastructure, the Chinese Biomedical Literature Database (SinoMed) and Wanfang Data from 1 January 2011 to 31 July 2022. All observational studies that reported long-term mortality of patients with DFU were included. Random effect models were used to pool the reconstructed participant data from Kaplan-Meier curves. The primary outcome was the long-term survival of patients with DFU. An aggregate data meta-analysis was also performed.
RESULTS
We identified 34 studies, with 124 376 participants representing 16 countries, among whom there were 51 386 deaths. Of these, 27 studies with 21 171 patients were included in the Kaplan-Meier-based meta-analysis. The estimated Kaplan-Meier-based survival rates were 86.9% (95% confidence interval [CI] 82.6%-91.5%) at 1 year, 66.9% (95% CI 59.3%-75.6%) at 3 years, 50.9% (95% CI 42.0%-61.7%) at 5 years and 23.1% (95% CI 15.2%-34.9%) at 10 years. The results of the aggregate data-based meta-analysis were similar. Cardiovascular disease and infection were the most common causes of death, accounting for 46.6% (95% CI 33.5%-59.7%) and 24.8% (95% CI 16.0%-33.5%), respectively. Patients with older age (per 1 year, hazard ratio [HR] 1.054, 95% CI 1.045-1.063), peripheral artery disease (HR 1.882, 95% CI 1.592-2.225), chronic kidney disease (HR 1.535, 95% CI 1.227-1.919), end-stage renal disease (HR 3.586, 95% CI 1.333-9.643), amputation (HR 2.415, 95% CI 1.323-4.408) and history of cardiovascular disease (HR 1.449, 95% CI 1.276-1.645) had higher mortality risk.
CONCLUSIONS
This meta-analysis found that the overall mortality of DFU was high, with nearly 50% mortality within 5 years. Cardiovascular disease and infection were the two leading causes of death.
Topics: Humans; Diabetic Foot; Cardiovascular Diseases; China; Diabetes Mellitus
PubMed: 36054820
DOI: 10.1111/dom.14840 -
International Wound Journal May 2022This study aims at evaluating the efficacy and safety of ozone therapy for chronic wounds. The Cochrane Library, PubMed, Ovid Embase, Web of Science, and Chinese...
This study aims at evaluating the efficacy and safety of ozone therapy for chronic wounds. The Cochrane Library, PubMed, Ovid Embase, Web of Science, and Chinese Biomedical Literature Database were searched. Randomised controlled trials (RCTs) about participants with chronic wounds were included. Risk of bias assessment was performed by the Cochrane risk-of-bias tool. A randomised-effects model was applied to pool results according to the types of wounds or ulcers. Among 12 included studies, ozone was implemented by topical application (ozone gas bath, ozonated oil, ozone water flushing) and systematic applications including autologous blood immunomodulation and rectal insufflation. The results indicated compared with standard control therapy for diabetic foot ulcers, ozone therapy regardless of monotherapy or combined control treatment markedly accelerated the improvement of the wound area(standardised mean difference(SMD) = 66.54%, 95% confidence interval (CI) = [46.18,86.90], P < .00001) and reduced the amputation rate (risk ration (RR) = 0.36, 95% CI = [0.24,0.54], P < .00001). But there is no improvement in the proportion of participants with completely healed wounds and length of hospital stay. No adverse events associated with ozone treatment have been reported. And the efficacy of ozone therapy for other wound types is still uncertain because of no sufficient studies. More high-quality randomised controlled trials are needed to confirm the efficacy and safety of ozone therapy for chronic wounds or ulcers.
Topics: Amputation, Surgical; Diabetic Foot; Humans; Ozone; Ulcer; Wound Healing
PubMed: 34612569
DOI: 10.1111/iwj.13687 -
European Journal of Vascular and... Aug 2020This review aims to assess the evidence supporting the impact of patient foot care education on self efficacy, self care behaviour, and self care knowledge in... (Review)
Review
OBJECTIVE
This review aims to assess the evidence supporting the impact of patient foot care education on self efficacy, self care behaviour, and self care knowledge in individuals with diabetes.
METHODS
This systematic review was registered prospectively on the PROSPERO database (CRD42019106171). Ovid EMBASE and MEDLINE databases were searched from 1946 to the end of March 2019, using search terms related to the domains diabetic foot, patient education, self efficacy, self care behaviour, and self care knowledge. All included studies were prospective, randomised controlled trials that assessed foot care education interventions in individuals with diabetes and recorded an outcome related to self efficacy, self care behaviour, and/or self care knowledge.
RESULTS
Thirteen randomised controlled trials were included, reporting on a total of 3948 individuals. The risk of bias was high or unclear in 11 of the 13 included studies, and low in two studies. Both the education interventions delivered, and the outcome assessment tools used were heterogenous across included studies: meta-analysis was therefore not performed. Eight of 11 studies identified significantly better foot self care behaviour scores in individuals randomised to education compared with controls. Self efficacy scores were significantly better in education groups in four of five studies reporting this primary outcome. Foot care knowledge was significantly better in intervention vs. control in three of seven studies. In general, studies assessing secondary endpoints including quality of life and ulcer/amputation incidence tended not to identify significant clinical improvements.
CONCLUSION
The available evidence is of inadequate quality to reliably conclude that foot care education has a positive impact on foot self care behaviour and self efficacy in individuals with diabetes. Quality data supporting accompanying benefits on quality of life or ulcer/amputation incidence are also lacking and should be considered as an important outcome measure in future studies.
Topics: Aged; Diabetic Foot; Female; Health Behavior; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Patient Education as Topic; Quality of Life; Randomized Controlled Trials as Topic; Self Care; Self Efficacy; Treatment Outcome; Wound Healing
PubMed: 32660807
DOI: 10.1016/j.ejvs.2020.03.053 -
Foot Self-Care Experiences Among Patients With Diabetes: A Systematic Review of Qualitative Studies.Wound Management & Prevention Apr 2020Research that explores foot self-care practices and clinical foot care recommendations for persons with diabetes mellitus is limited.
UNLABELLED
Research that explores foot self-care practices and clinical foot care recommendations for persons with diabetes mellitus is limited.
PURPOSE
The aim of this systematic review was to understand the gaps between the American Diabetes Association clinical recommendations on preventive foot self-care and perceptions of and actions taken by patients with diabetes and diabetic foot ulcers (DFUs).
METHODS
PubMed, the Cumulative Index of Nursing and Allied Health Literature, Cochrane Online Library, Psychological Information Database, and Google Scholar were systematically searched for qualitative research literature published in English from January 1, 2001, to October 21, 2016, using the MeSH terms diabetes mellitus, diabetic foot ulcers, foot care, experiences, and perception to examine the experiences of patients with diabetes regarding foot self-care practices. Publications were screened for inclusion according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and The Standard for Reporting Qualitative Research was used to appraise trustworthiness and publication bias. Publication details (author, year, title, country in which the study was conducted, and the type of publication), study aims, design (study methodology, method of sampling, and analysis method), and participant details were abstracted to Excel sheets for analysis of foot self-care experiences and to determine common themes (foot self-care issues) among patients with diabetes.
RESULTS
Of the 14 publications identified, 9 (that included 113 patients with diabetes [95 with or history of DFUs and 18 with no DFUs] and 28 health care professionals [14 podiatrists, 8 physicians, and 6 registered nurses]) met the inclusion criteria for analysis. Research included 4 qualitative descriptive design studies, 2 descriptive phenomenology studies, 1 grounded theory study, 1 interpretive phenomenology study, and 1 exploratory qualitative design study. Four (4) studies were found to lack transparency, and 7 studies did not address trustworthiness. The common themes identified were the high clinical and lifestyle burden of DFUs, poor foot self-care knowledge, perception barriers and resistance, adoption of self-management practices, and discordance between patient and provider impressions and expectations.
CONCLUSION
Several barriers to optimal foot care in persons with diabetes with and without foot ulcers were identified and may be explained and addressed by considering the Health Belief Model. Clinical interventions should be individualized to identify and address patient-specific barriers to optimal foot self-care. Future clinical studies are needed to examine the outcomes of individualized interventions.
Topics: Diabetes Mellitus; Diabetic Foot; Humans; Self Care
PubMed: 32294056
DOI: 10.25270/wmp.2020.4.1625 -
Diabetes/metabolism Research and Reviews Mar 2024Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are...
AIMS
Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes-related foot ulcer. However, the rising incidence and costs of diabetes-related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes-related foot ulcers are supported by high-quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold-standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.
MATERIALS AND METHODS
We followed the GRADE approach by devising clinical questions and important outcomes in the Patient-Intervention-Control-Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.
RESULTS
From the results of the systematic review and evidence-to-decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post-operative wounds, the use of placental-derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.
CONCLUSIONS
These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.
Topics: Pregnancy; Female; Humans; Diabetic Foot; Placenta; Foot Ulcer; Wound Healing; Diabetes Mellitus
PubMed: 37232034
DOI: 10.1002/dmrr.3644 -
Journal of Vascular Surgery Apr 2020Multiple single-center studies have reported significant reductions in major amputations among patients with diabetic foot ulcers after initiation of multidisciplinary...
OBJECTIVE
Multiple single-center studies have reported significant reductions in major amputations among patients with diabetic foot ulcers after initiation of multidisciplinary teams. The purpose of this study was to assess the association between multidisciplinary teams (ie, two or more types of clinicians working together) and the risk of major amputation and to compile descriptions of these diverse teams.
METHODS
We searched PubMed, Scopus, Cumulative Index to Nursing and Allied Health, and Cochrane Central Register of Controlled Trials from inception through May 24, 2019 for studies reporting the association between multidisciplinary teams and major amputation rates for patients with diabetic foot ulcers. We included original studies if ≥50% of the patients seen by the multidisciplinary team had diabetes, they included a control group, and they reported the effect of a multidisciplinary team on major amputation rates. Studies were excluded if they were non-English language, abstracts only, or unpublished. We used the five-domain Systems Engineering Initiative for Patient Safety Model to describe team composition and function and summarized changes in major amputation rates associated with multidisciplinary team care. A meta-analysis was not performed because of heterogeneity across studies, their observational designs, and the potential for uncontrolled confounding (PROSPERO No. 2017: CRD42017067915).
RESULTS
We included 33 studies, none of which were randomized trials. Multidisciplinary team composition and functions were highly diverse. However, four elements were common across teams: teams were composed of medical and surgical disciplines; larger teams benefitted from having a "captain" and a nuclear and ancillary team member structure; clear referral pathways and care algorithms supported timely, comprehensive care; and multidisciplinary teams addressed four key tasks: glycemic control, local wound management, vascular disease, and infection. Ninety-four percent (31/33) of studies reported a reduction in major amputations after institution of a multidisciplinary team.
CONCLUSIONS
Multidisciplinary team composition was variable but reduced major amputations in 94% of studies. Teams consistently addressed glycemic control, local wound management, vascular disease, and infection in a timely and coordinated manner to reduce major amputation for patients with diabetic foot ulcerations. Care algorithms and referral pathways were key tools to their success.
Topics: Amputation, Surgical; Diabetic Foot; Humans; Limb Salvage; Patient Care Team
PubMed: 31676181
DOI: 10.1016/j.jvs.2019.08.244 -
Frontiers in Neurology 2023Painful Diabetic Peripheral Neuropathy (PDPN) is a common complication of diabetes, it severely affects the quality of life of patients. Acupuncture has been shown to be...
BACKGROUND
Painful Diabetic Peripheral Neuropathy (PDPN) is a common complication of diabetes, it severely affects the quality of life of patients. Acupuncture has been shown to be effective in the treatment of PDPN. To evaluate the efficacy and safety of acupuncture for pain relief in patients diagnosed with diabetic peripheral neuropathy, we conducted a systematic review and meta-analysis.
METHOD
We thoroughly searched specific databases, which included PUBMED, EMBASE, Web of Science, the Cochrane Library, the Chinese Biomedical Literature Database, the Chinese National Knowledge Infrastructure, China Science and Technology Journal Database and the Wanfang Data. All randomized controlled trials of acupuncture therapy for PDPN with pain change scales were included. Included studies were assessed for methodological quality according to the risk of bias from the Cochrane handbook. Meta-analyses were carried out to analyze the outcomes, subgroup analyses, sensitivity analyses, and funnel plot analyses were undertaken.
RESULTS
This systematic review evaluated a total of 25 trials of acupuncture therapy in combination with conventional treatment, involving a total of 1,561 patients with PDPN. According to the results, among 16 trials using VAS scores with a total of 1,552 patients, 2 acupoint injection trials (MD -2.38, 95% CI: -2.76 to -2.01, < 0.00001), 12 acupuncture trials (MD -1. 31, 95% CI: -1.60 to -1.02, < 0.00001) and 2 moxibustion trials showed that acupuncture therapy combined with conventional treatment improved pain better than conventional treatment (MD -2.50, 95% CI: -2.76 to -2.24, < 0.00001). In the subgroup analysis of the acupuncture group, the results of the 5 trials in which the location of acupuncture was only in the limbs (MD -1.27, 95% CI: -1.54 to -1.01, < 0.00001) and the 7 trials both in limbs and torso (MD -1.38, 95% CI: -1.81 to -0.95, < 0.00001) also demonstrated that acupuncture was effective in pain improvement.
CONCLUSION
This meta-analysis analyzed the possible efficacy of acupuncture in combination with conventional treatment for pain in diabetic peripheral neuropathy, particularly when acupoints are located in the limbs. However, there are limitations to this meta-analysis and future clinical studies are needed to confirm these findings.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023449447, identifier (CRD42023449447).
PubMed: 38046594
DOI: 10.3389/fneur.2023.1281485 -
Diabetes Care Oct 2022Different waveforms of spinal cord stimulation (SCS) have now been evaluated for the management of painful diabetic neuropathy (PDN). However, no direct or indirect... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Different waveforms of spinal cord stimulation (SCS) have now been evaluated for the management of painful diabetic neuropathy (PDN). However, no direct or indirect comparison between SCS waveforms has been performed to date.
PURPOSE
To conduct a systematic review and network meta-analysis to evaluate the effectiveness of SCS for PDN.
DATA SOURCES
MEDLINE, CENTRAL, Embase, and WikiStim were searched from inception until December 2021.
STUDY SELECTION
Randomized controlled trials (RCTs) of SCS for PDN were included.
DATA EXTRACTION
Pain intensity, proportion of patients achieving at least a 50% reduction in pain intensity, and health-related quality of life (HRQoL) data were extracted.
DATA SYNTHESIS
Significant reductions in pain intensity were observed for low-frequency SCS (LF-SCS) (mean difference [MD] -3.13 [95% CI -4.19 to -2.08], moderate certainty) and high-frequency SCS (HF-SCS) (MD -5.20 [95% CI -5.77 to -4.63], moderate certainty) compared with conventional medical management (CMM) alone. There was a significantly greater reduction in pain intensity on HF-SCS compared with LF-SCS (MD -2.07 [95% CI -3.26 to -0.87], moderate certainty). Significant differences were observed for LF-SCS and HF-SCS compared with CMM for the outcomes proportion of patients with at least 50% pain reduction and HRQoL (very low to moderate certainty). No significant differences were observed between LF-SCS and HF-SCS (very low to moderate certainty).
LIMITATIONS
Limited number of RCTs and no head-to-head RCTs conducted.
CONCLUSIONS
Our findings confirm the pain relief and HRQoL benefits of the addition of SCS to CMM for patients with PDN. However, in the absence of head-to-head RCT evidence, the relative benefits of HF-SCS compared with LF-SCS for patients with PDN remain uncertain.
Topics: Diabetes Mellitus; Diabetic Neuropathies; Humans; Network Meta-Analysis; Pain; Pain Measurement; Spinal Cord Stimulation
PubMed: 36150057
DOI: 10.2337/dc22-0932 -
Scientific Reports Jan 2021Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore,... (Meta-Analysis)
Meta-Analysis
Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14-0.61; I = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39-0.92; I = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34-1.97; I = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07-2.65; I = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.
Topics: Amputation, Surgical; Controlled Clinical Trials as Topic; Diabetic Foot; Humans; Hyperbaric Oxygenation; Publication Bias; Risk; Treatment Outcome; Wound Healing
PubMed: 33500533
DOI: 10.1038/s41598-021-81886-1