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International Wound Journal Feb 2024This systematic review aimed to qualitatively synthesize recent randomized controlled trials (RCTs) regarding the effect of topical application and oral intake of herbal... (Meta-Analysis)
Meta-Analysis Review
This systematic review aimed to qualitatively synthesize recent randomized controlled trials (RCTs) regarding the effect of topical application and oral intake of herbal products on the healing of diabetic foot ulcer (DFU). Also, we sought to pool the obtained findings in a meta-analysis using a random-effects model, if RCTs were relatively comparable and homogenous. A comprehensive search was performed on five electronic data sources from their inception through 23 January 2024. The RCTs, without restriction on the country of origin, were included if they compared the effect of administering standard treatments and/or placebo (i.e. control condition) to applying standard treatments and/or herbal products in topical or oral routes (i.e. experimental condition). Out of 1166 retrieved records, 28 RCTs were included. Studies used different poly and single herbal formulations. Based on the meta-analysis, administration of standard care plus daily dressing of the ulcer site with olive oil for 28 days significantly increased the total ulcer healing score (3 RCTs; weighted mean difference [WMD] = 89.30; p < 0.001), raised frequency of complete ulcer healing (2 RCTs; risk ratio [RR] = 12.44; p = 0.039) and declined ulcer degree (3 RCTs; WMD = -22.28; p = 0.002). Also, daily use of the bitter melon leaf extract in oral form for 28 days significantly increased the total ulcer healing score (2 RCTs; WMD = 0.40; p = 0.001). Additionally, based on qualitative synthesis, the adjuvant use of herbal agents seems an intriguing choice to manage DFU. Nonetheless, considering the undesirable methodological quality of most studies and the high heterogeneity in administered herbal formulations, more robust trials are required to build a solid conclusion regarding the use of herbal products for healing DFU.
Topics: Humans; Diabetic Foot; Randomized Controlled Trials as Topic; Ulcer; Bandages; Administration, Oral; Diabetes Mellitus
PubMed: 38356150
DOI: 10.1111/iwj.14760 -
Journal of Medical Internet Research Oct 2023Globally, diabetes affects approximately 500 million people and is predicted to affect up to 700 million people by 2045. In Australia, the ongoing impact of colonization... (Review)
Review
BACKGROUND
Globally, diabetes affects approximately 500 million people and is predicted to affect up to 700 million people by 2045. In Australia, the ongoing impact of colonization produces inequity in health care delivery and inequality in health care outcomes for First Nations Peoples, with diabetes rates 4 times those of non-Indigenous Australians. Evidence-based clinical practice has been shown to reduce complications of diabetes-related foot disease, including ulceration and amputation, by 50%. However, factors such as a lack of access to culturally safe care, geographical remoteness, and high costs associated with in-person care are key barriers for First Nations Peoples in accessing evidence-based care, leading to the development of innovative mobile health (mHealth) apps as a way to increase access to health services and improve knowledge and self-care management for people with diabetes.
OBJECTIVE
This study aims to evaluate studies investigating the use of mHealth apps for the assessment and management of diabetes-related foot health in First Nations Peoples in Australia and non-Indigenous populations globally.
METHODS
PubMed, Informit's Indigenous Collection database, Ovid MEDLINE, Embase, CINAHL Complete, and Scopus were searched from inception to September 8, 2022. Hand searches of gray literature and reference lists of included studies were conducted. Studies describing mHealth apps developed for the assessment and management of diabetes-related foot health were eligible. Studies must include an evaluation (qualitative or quantitative) of the mHealth app. No language, publication date, or publication status restrictions were used. Quality appraisal was performed using the revised Cochrane risk-of-bias tool for randomized trials and the Health Evidence Bulletins Wales checklists for observational, cohort, and qualitative studies.
RESULTS
No studies specifically including First Nations Peoples in Australia were identified. Six studies in non-Indigenous populations with 361 participants were included. Foot care education was the main component of all mHealth apps. Of the 6 mHealth apps, 2 (33%) provided functionality for participants to enter health-related data; 1 (17%) included a messaging interface. The length of follow-up ranged from 1-6 months. Of the 6 studies, 1 (17%) reported high levels of acceptability of the mHealth app content for self-care by people with diabetes and diabetes specialists; the remaining 5 (83%) reported that participants had improved diabetes-related knowledge and self-management skills after using their mHealth app.
CONCLUSIONS
The findings from this systematic review provide an overview of the features deployed in mHealth apps and indicate that this type of intervention can improve knowledge and self-care management skills in non-Indigenous people with diabetes. Future research needs to focus on mHealth apps for populations where there is inadequate or ineffective service delivery, including for First Nations Peoples and those living in geographically remote areas, as well as evaluate direct effects on diabetes-related foot disease outcomes.
TRIAL REGISTRATION
PROSPERO CRD42022349087; https://tinyurl.com/35u6mmzd.
Topics: Humans; Mobile Applications; Australia; Telemedicine; Diabetic Foot; Foot Diseases; Diabetes Mellitus
PubMed: 37792467
DOI: 10.2196/47608 -
Renal Failure Dec 2024To determine the efficacy and safety of Astragalus combined with renin-angiotensin-aldosterone system (RAAS) blockers in treating stage III diabetic nephropathy (DN) by... (Meta-Analysis)
Meta-Analysis
Efficacy of astragalus combined with renin-angiotensin-aldosterone system blockers in the treatment of stage III diabetic nephropathy: a systematic review and meta-analysis.
OBJECTIVE
To determine the efficacy and safety of Astragalus combined with renin-angiotensin-aldosterone system (RAAS) blockers in treating stage III diabetic nephropathy (DN) by meta-analysis.
METHODS
PubMed, Embase, Cochrane Library, Wiley, and Web of Science databases were searched for articles published between August 2007 and August 2022. Clinical studies on Astragalus combined with RAAS blockers for the treatment of stage III DN were included. Meta-analysis was performed by RevMan 5.1 and Stata 14.3 software.
RESULTS
A total of 32 papers were included in this meta-analysis, containing 2462 patients from randomized controlled trials, with 1244 receiving the combination treatment and 1218 solely receiving RAAS blockers. Astragalus combined with RAAS blockers yielded a significantly higher total effective rate (TER) (mean difference [MD] 3.63, 95% confidence interval [CI] 2.59-5.09) and significantly reduced urinary protein excretion rate (UPER), serum creatinine (Scr), blood urine nitrogen (BUN) and glycosylated hemoglobin (HbAlc) levels. In subgroup analysis, combining astragalus and angiotensin receptor blocker significantly lowered fasting plasma glucose (FPG) and 24 h urinary protein (24hUTP) levels, compared with the combined astragalus and angiotensin-converting enzyme inhibitor treatment. Meanwhile, the latter significantly decreased the urinary microprotein (β-MG). Importantly, the sensitivity analysis confirmed the study's stability, and publication bias was not detected for UPER, BUN, HbAlc, FPG, or β-MG. However, the TER, SCr, and 24hUTP results suggested possible publication bias.
CONCLUSIONS
The astragalus-RAAS blocker combination treatment is safe and improves outcomes; however, rigorous randomized, large-scale, multi-center, double-blind trials are needed to evaluate its efficacy and safety in stage III DN.
Topics: Humans; Diabetic Nephropathies; Angiotensin-Converting Enzyme Inhibitors; Renin-Angiotensin System; Drug Therapy, Combination; Angiotensin Receptor Antagonists; Astragalus Plant; Randomized Controlled Trials as Topic; Drugs, Chinese Herbal; Treatment Outcome; Creatinine; Glycated Hemoglobin; Proteinuria
PubMed: 38836372
DOI: 10.1080/0886022X.2024.2359033 -
Frontiers in Endocrinology 2023This study aimed to evaluate the effectiveness of total contact casts (TCCs) versus removable offloading interventions among patients with diabetic foot ulcers (DFUs). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This study aimed to evaluate the effectiveness of total contact casts (TCCs) versus removable offloading interventions among patients with diabetic foot ulcers (DFUs).
METHODS
A comprehensive search was done in databases Embase, Cochrane Library, and, PubMed. The references of retrieved articles were reviewed, up until February 2023. Controlled trials comparing the effects of TCCs with removable offloading interventions (removable walking casts and footwear) in patients with DFUs were eligible for review.
RESULTS
Twelve studies were included in the meta-analysis, involving 591 patients with DFUs. Among them, 269 patients were in the intervention group (TCC), and 322 in the control group (removable walking casts/footwear). The analysis revealed that the TCC group had higher healing rates (Risk Ratio(RR)=1.22; 95% confidence interval(CI):1.11 to 1.34, p<0.001), shorter healing time (Standard Mean Difference(SMD)=-0.57; 95%CI: -1.01 to -0.13, P=0.010), and elevated occurrence of device-related complications (RR=1.70; 95%CI:1.01 to 2.88, P=0.047), compared with the control group. Subgroup analysis illustrated patients using TCCs had higher healing rates than those using removable walking casts (RR=1.20; 95%CI:1.08 to 1.34, p=0.001) and footwear (RR=1.25; 95%CI:1.04 to 1.51, p=0.019), but they required comparable time for ulcer healing compared with those using removable walking casts (SMD=-0.60; 95%CI: -1.22 to 0.02, P=0.058) or footwear group (SMD=-0.52; 95%CI: -1.17 to 0.12, P=0.110). Although patients using TCCs had significantly higher incidence of device-related complications than those using footwear (RR=4.81; 95%CI:1.30 to 17.74, p=0.018), they had similar one compared with those using the removable walking casts (RR=1.27; 95%CI:0.70 to 2.29, p=0.438).
CONCLUSION
The use of TCCs in patients with DFUs resulted in improved rates of ulcer healing and shorter healing time compared to removable walking casts and footwear. However, it is important to note that TCCs were found to be associated with increased prevalence of complications.
Topics: Humans; Diabetic Foot; Casts, Surgical; Wound Healing; Walking; Diabetes Mellitus
PubMed: 37822605
DOI: 10.3389/fendo.2023.1234761 -
Diabetes Research and Clinical Practice Dec 2023Living with a diabetes-related foot ulcer has significant lifestyle impacts. Whilst often considered a last resort, amputation can overcome the burden of ulcer... (Review)
Review
Living with a diabetes-related foot ulcer has significant lifestyle impacts. Whilst often considered a last resort, amputation can overcome the burden of ulcer management, for an improved quality of life. However, limited research has been conducted to understand how the decision to amputate is made for people with a chronic ulcer when amputation is not required as a medical emergency. Therefore, the aim was to identify and map key concepts in the literature which describe the decision-making for diabetes-related amputations. This review followed Arksey and O'Malley's PRISMA scoping review framework. Five electronic databases and grey literature were searched for papers which described clinical reasoning and/or decision-making processes for diabetes-related amputation. Data were extracted and mapped to corresponding domains of the World Health Organisation's International Classification of functioning, Disability and Health (ICF) framework. Ninety-four papers were included. Personal factors including emotional wellbeing, quality of life, and treatment goals are key considerations for an elective amputation. It is important to consider an individual's lifestyle and personal circumstances, as well as the pathology when deciding between amputation or conservative management. This highlights the importance of a holistic and shared decision-making process for amputation which includes assessment of a person's lifestyle and function.
Topics: Humans; Quality of Life; Ulcer; Amputation, Surgical; Diabetic Foot; Lower Extremity; Diabetes Mellitus
PubMed: 37981124
DOI: 10.1016/j.diabres.2023.111015 -
Wound Repair and Regeneration :... 2024Transmetatarsal amputation (TMA) is a common surgical procedure for addressing severe forefoot pathologies, such as peripheral vascular disease and diabetic foot... (Meta-Analysis)
Meta-Analysis Review
Transmetatarsal amputation (TMA) is a common surgical procedure for addressing severe forefoot pathologies, such as peripheral vascular disease and diabetic foot infections. Variability in research methodologies and findings within the existing literature has hindered a comprehensive understanding of healing rates and complications following TMA. This meta-analysis and systematic review aims to consolidate available evidence, synthesising data from multiple studies to assess healing rates and complications associated with closed TMA procedures. Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a systematic search of Medline, Embase, and Cochrane databases was conducted for articles published from January 1st, 1988, to June 1st, 2023. Inclusion criteria comprised studies reporting healing rates in non-traumatic transmetatarsal amputation patients with more than 10 participants, excluding open TMAs. Two independent reviewers selected relevant studies, with disagreements resolved through discussion. Data extracted from eligible studies included patient demographics, healing rates, complications, and study quality. Among 22 studies encompassing 1569 transmetatarsal amputations, the pooled healing rate was 67.3%. Major amputation rates ranged from 0% to 55.6%, with a random-effects pooled rate of 23.9%. Revision rates varied from 0% to 36.4%, resulting in a pooled rate of 14.8%. 30-day mortality ranged from 0% to 9%, with a fixed-effects pooled rate of 2.6%. Post-operative infection rates ranged from 3.0% to 30.7%, yielding a random-effects pooled rate of 16.7%. Dehiscence rates ranged from 1.7% to 60.0%, resulting in a random-effects pooled rate of 28.8%. Future studies should aim for standardised reporting and assess the physiological and treatment factors influencing healing and complications.
Topics: Humans; Wound Healing; Foot; Amputation, Surgical; Diabetic Foot; Peripheral Vascular Diseases
PubMed: 38111147
DOI: 10.1111/wrr.13143 -
Primary Care Diabetes Apr 2024We conducted a systematic review and meta-analysis to investigate the effect of exercise training on HbA1c, and on fasting and postprandial plasma glucose concentrations... (Meta-Analysis)
Meta-Analysis Review
AIMS
We conducted a systematic review and meta-analysis to investigate the effect of exercise training on HbA1c, and on fasting and postprandial plasma glucose concentrations in patients with diabetic peripheral neuropathy (DPN).
METHODS
Two independent researchers performed a systematic search in the electronic databases of PubMed, Web of Science and Scopus. Studies investigating the effect of exercise training on patients diagnosed with DPN using a randomized-controlled design were included in the meta-analysis.
RESULTS
Of 1254 retrieved studies, 68 studies were identified to undergo full-text review; out of these a total of 13 randomized trials met the inclusion criteria. Eleven studies assessed HbA1c, 8 fasting plasma-glucose concentration, and 3 postprandial plasma-glucose concentration. Overall, exercise training significantly decreased HbA1c [-0.54% (95% CI -0.78 to -0.31%)], fasting plasma glucose [-32.6 mg/dl [-1.8 mmol/L] (-44.2 to -20.9 mg/dl [-2.4 to -1.1 mmol/L])] and postprandial plasma glucose [-67.5 mg/dl [-3.7 mmol/L] (-129.5 to -5.4 mg/dl [-7.1 to -0.3 mmol/L])]. Studies with aerobic training intervention yielded the largest significant mean reduction in HbA1c (-0.75%) and fasting plasma glucose concertation (34.0 mg/dl).
CONCLUSIONS
aerobic training is the most effective modality to reduces HbA1c, fasting and postprandial plasma glucose concentration in patients with DPN. From a metabolic perspective, the magnitude precision range of the reduction in HbA1c is of clinical importance for patients with DPN. This area of research warrants further attention to investigate the impact of various exercise modalities on glycemic control. Registration number CRD42023413687.
Topics: Humans; Blood Glucose; Glycated Hemoglobin; Diabetes Mellitus, Type 2; Glycemic Control; Diabetic Neuropathies; Exercise; Randomized Controlled Trials as Topic
PubMed: 38286719
DOI: 10.1016/j.pcd.2024.01.008 -
Heliyon Mar 2024Diabetes mellitus (DM) is one of the fastest-growing diseases worldwide; however, its pathogenesis remains unclear. Complications seriously affect the quality of life of... (Review)
Review
CONTEXT
Diabetes mellitus (DM) is one of the fastest-growing diseases worldwide; however, its pathogenesis remains unclear. Complications seriously affect the quality of life of patients in the later stages of diabetes, ultimately leading to suffering. Natural small molecules are an important source of antidiabetic agents.
OBJECTIVE
Astragaloside IV (AS-IV) is an active ingredient of Astragalus mongholicus (Fisch.) Bunge. We reviewed the efficacy and mechanism of action of AS-IV in animal and cellular models of diabetes and the mechanism of action of AS-IV on diabetic complications in animal and cellular models. We also summarized the safety of AS-IV and provided ideas and rationales for its future clinical application.
METHODS
Articles on the intervention in DM and its complications using AS-IV, such as those published in SCIENCE, PubMed, Springer, ACS, SCOPUS, and CNKI from the establishment of the database to February 2022, were reviewed. The following points were systematically summarized: dose/concentration, route of administration, potential mechanisms, and efficacy of AS-IV in animal models of DM and its complications.
RESULTS
AS-IV has shown therapeutic effects in animal models of DM, such as alleviating gestational diabetes, delaying diabetic nephropathy, preventing myocardial cell apoptosis, and inhibiting vascular endothelial dysfunction; however, the potential effects of AS-IV on DM should be investigated.
CONCLUSION
AS-IV is a potential drug for the treatment of diabetes and its complications, including diabetic vascular disease, cardiomyopathy, retinopathy, peripheral neuropathy, and nephropathy. In addition, preclinical toxicity studies indicate that it appears to be safe, but the safe human dose limit is yet to be determined, and formal assessments of adverse drug reactions among humans need to be further investigated. However, additional formulations or structural modifications are required to improve the pharmacokinetic parameters and facilitate the clinical use of AS-IV.
PubMed: 38439832
DOI: 10.1016/j.heliyon.2024.e26863 -
Diabetes/metabolism Research and Reviews Mar 2024Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes-related foot ulcers. This is the 2023 International... (Meta-Analysis)
Meta-Analysis
AIMS
Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes-related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on offloading 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 PICO (Patient-Intervention-Control-Outcome) format, undertaking a systematic review and meta-analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability.
RESULTS
For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non-removable knee-high offloading device as the first-choice offloading intervention. If contraindications or patient intolerance to non-removable offloading exist, consider using a removable knee-high or ankle-high offloading device as the second-choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third-choice offloading intervention. If such a non-surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non-plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice.
CONCLUSION
These offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes-related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.
Topics: Humans; Diabetic Foot; Ulcer; Foot Ulcer; Foot; Wound Healing; Diabetes Mellitus
PubMed: 37226568
DOI: 10.1002/dmrr.3647 -
Scientific Reports Sep 2023The number of diabetic foot ulcer patients is substantially increasing, with the rapidly rising burden of diabetic mellitus in sub-Saharan Africa. The data on the... (Meta-Analysis)
Meta-Analysis
The number of diabetic foot ulcer patients is substantially increasing, with the rapidly rising burden of diabetic mellitus in sub-Saharan Africa. The data on the regional prevalence of diabetic foot ulcer infecting bacteria and their antimicrobial resistance patterns is crucial for its proper management. This systematic review and meta-analysis determined the pooled prevalence of bacterial profiles and antimicrobial resistance patterns of infected diabetic foot ulcers in sub-Saharan Africa. A comprehensive search of the literature was performed on CINAHL, EMBASE, Google Scholar, PubMed, Scopus, and Web of Science databases. Critical appraisal was done using the Joanna Briggs Institute's tool for prevalence studies. A pooled statistical meta-analysis was conducted using STATA Version 17.0. The I statistics and Egger's test were used to assess the heterogeneity and publication bias. The pooled prevalence and the corresponding 95% confidence interval of bacterial profiles and their antimicrobial resistance patterns were estimated using a random effect model. Eleven studies with a total of 1174 study participants and 1701 bacteria isolates were included. The pooled prevalence of the most common bacterial isolates obtained from DFU were S. aureus (34.34%), E. coli (21.16%), and P. aeruginosa (20.98%). The highest pooled resistance pattern of S. aureus was towards Gentamicin (57.96%) and Ciprofloxacin (52.45%). E.coli and K. Pneumoniae showed more than a 50% resistance rate for the most common antibiotics tested. Both gram-positive and gram-negative bacteria were associated with diabetic foot ulcers in sub-Saharan Africa. Our findings are important for planning treatment with the appropriate antibiotics in the region. The high antimicrobial resistance prevalence rate indicates the need for context-specific effective strategies aimed at infection prevention and evidence-based alternative therapies.
Topics: Humans; Diabetic Foot; Anti-Bacterial Agents; Gram-Negative Bacteria; Escherichia coli; Staphylococcus aureus; Drug Resistance, Bacterial; Gram-Positive Bacteria; Bacteria; Africa South of the Sahara; Diabetes Mellitus
PubMed: 37670001
DOI: 10.1038/s41598-023-41882-z