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Journal of Foot and Ankle Research Mar 2023Offloading devices improve healing of diabetes-related foot ulcers (DFUs) but they can limit mobilisation. Rehabilitation during or after removal of these devices may... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Offloading devices improve healing of diabetes-related foot ulcers (DFUs) but they can limit mobilisation. Rehabilitation during or after removal of these devices may promote physical activity in a population at risk of poor health outcomes for which inactivity is a reversible risk factor.
METHODS
This systematic review examined the effectiveness of rehabilitation interventions to promote physical activity during and/or after wearing an offloading device to treat diabetes-related foot ulcers. Searches using MESH terms and free-text combinations: 'foot ulcer', 'diabetic foot', 'casts, surgical', 'orthotic devices' were applied to MEDLINE, Embase, The Cochrane Library and clinical trial registers for randomised and observational studies published to September 2022. Methodological quality assessment of included studies was undertaken using the Cochrane Risk of Bias (RoB 2.0) and Risk of Bias In Non-randomised studies of Interventions (ROBINS-I) tools.
RESULTS
Of 3332 records identified, eight studies (441 participants), four clinical trials and four cohort studies, were included. None delivered or tested a structured rehabilitation programme, but all reported physical activity outcomes during or after device use. People wearing non-removable total contact casts were less active than those wearing devices (SMD -0.45; 95% CI - 0.87 to - 0.04; p = 0.03; I 56%; 4 trials). Diabetes-related foot ulcers in people wearing total contact casts were more likely to heal compared to removable devices at 12 weeks (OR 2.69; 95% CI 0.97 to 7.45; p = 0.06; I = 64%; 4 trials) and 20 weeks (OR 2.35; 95% CI 0.95 to 5.82; p = 0.07; I = 65%; 4 trials).
CONCLUSIONS
Despite physical activity being low throughout off-loading treatment, no studies have specifically tested rehabilitation. There is a need to investigate the clinical and cost-effectiveness of rehabilitation programmes in this population. High quality trials are needed to provide robust evidence to support to rehabilitation after DFU treatment.
Topics: Humans; Ulcer; Diabetic Foot; Foot Ulcer; Wound Healing; Orthotic Devices; Diabetes Mellitus
PubMed: 36966316
DOI: 10.1186/s13047-023-00614-2 -
Frontiers in Pharmacology 2023The objective of this systematic review and meta-analysis is to assess the effectiveness and security of Chinese herbal medicine (CHM) in the therapy of painful...
The objective of this systematic review and meta-analysis is to assess the effectiveness and security of Chinese herbal medicine (CHM) in the therapy of painful diabetic neuropathy (PDN). We searched databases for randomized controlled trials (RCTs) of CHM in the treatment of PDN. Outcome indicators included nerve conduction velocity, clinical efficiency, pain score, TCM syndrome score, and adverse events. Stata 16.0 was used to carry out the Meta-analysis. A total of 21 RCTs with 1,737 participants were included. This meta-analysis found that using CHM as adjuvant treatment or as monotherapy for PDN can improve SCV of median nerve [mean difference (MD) = 3.56, 95% Confidence interval (CI) (2.19, 4.92) ], MCV of median nerve [ MD = 3.82, 95% CI (2.51, 5.12) ], SCV of common peroneal nerve [ MD = 4.16, 95% CI (1.62, 6.70) ], MCV of common peroneal nerve [ MD = 4.37, 95% CI (1.82, 6.93) ], SCV of gastrocnemius nerve [ MD = 4.95, 95% CI (3.52, 6.37) ], SCV of tibial nerve [ MD = 3.17, 95% CI (-2.64, 8.99) ], MCV of tibial nerve [MD = 6.30, 95%CI (5.00, 7.60)] and clinical effective rate [ odds ratio (OR) = 4.00, 95% CI (2.89, 5.52) ] and reduce pain score [standardized mean difference (SMD) = -2.23, 95% CI (-3.04, -1.41) ], TCM syndrome score [ MD = -4.70, 95% CI (-6.61, -2.80) ]. In addition, compared to the control group, adverse events of Chinese medicine intervention occurred less. CHM as adjuvant therapy or single treatment has a good curative effect and is safe for patients with PDN, which is worthy of clinical promotion and use, however; higher quality clinical studies are still needed to prove. https://www.crd.york.ac.uk/, identifier CRD42022327967.
PubMed: 36950007
DOI: 10.3389/fphar.2023.1072991 -
Systematic Reviews Mar 2023Painful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Painful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo treatments in terms of their efficacy and safety in patients with PDPN.
METHODS
Following the PRISMA guidelines, we searched the Cochrane Library, PubMed, and Embase databases for relevant English articles published before January 11, 2021. Treatment efficacy and safety were assessed in terms of pain improvement, patient-reported health-related performance, and patients' quality of life.
RESULTS
We reviewed a total of 7 randomized controlled trials. Regarding pain improvement, duloxetine was more efficacious than placebo (mean difference [MD] - 0.89; 95% confidence interval [CI] - 1.09 to - 0.69; P < .00001). Furthermore, duloxetine significantly improved the patients' quality of life, which was assessed using the Clinical Global Impression severity subscale (MD - 0.48; 95% CI - 0.61 to - 0.36; P < .00001), Patient Global Impression of Improvement scale (MD - 0.50; 95% CI - 0.64 to - 0.37; P < .00001), and European Quality of Life Instrument 5D version (MD 0.04; 95% CI 0.02 to 0.07; P = .0002). Severe adverse events were rare, whereas nausea, somnolence, dizziness, fatigue, constipation, and decreased appetite were common; approximately, 12.6% of all patients dropped out because of the common symptoms.
CONCLUSIONS
Duloxetine is more efficacious than placebo treatments in patients with PDPN. The rarity of severe adverse events indicates that duloxetine is safe. When a 60-mg dose is insufficient, 120 mg of duloxetine may improve PDPN symptoms. Our findings may help devise optimal treatment strategies for PDPN.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42021225451.
Topics: Humans; Duloxetine Hydrochloride; Diabetic Neuropathies; Quality of Life; Randomized Controlled Trials as Topic; Pain; Diabetes Mellitus
PubMed: 36945033
DOI: 10.1186/s13643-023-02185-6 -
Frontiers in Public Health 2023Early identification and intervention of diabetic peripheral neuropathy is beneficial to improve clinical outcome. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Early identification and intervention of diabetic peripheral neuropathy is beneficial to improve clinical outcome.
OBJECTIVE
To establish a risk prediction model for diabetic peripheral neuropathy (DPN) in patients with type 2 diabetes mellitus (T2DM).
METHODS
The derivation cohort was from a meta-analysis. Risk factors and the corresponding risk ratio (RR) were extracted. Only risk factors with statistical significance were included in the model and were scored by their weightings. An external cohort were used to validate this model. The outcome was the occurrence of DPN.
RESULTS
A total of 95,604 patients with T2DM from 18 cohorts were included. Age, smoking, body mass index, duration of diabetes, hemoglobin A1c, low HDL-c, high triglyceride, hypertension, diabetic retinopathy, diabetic kidney disease, and cardiovascular disease were enrolled in the final model. The highest score was 52.0. The median follow-up of validation cohort was 4.29 years. The optimal cut-off point was 17.0, with a sensitivity of 0.846 and a specificity of 0.668, respectively. According to the total scores, patients from the validation cohort were divided into low-, moderate-, high- and very high-risk groups. The risk of developing DPN was significantly increased in moderate- (RR 3.3, 95% CI 1.5-7.2, = 0.020), high- (RR 15.5, 95% CI 7.6-31.6, < 0.001), and very high-risk groups (RR 45.0, 95% CI 20.5-98.8, < 0.001) compared with the low-risk group.
CONCLUSION
A risk prediction model for DPN including 11 common clinical indicators were established. It is a simple and reliable tool for early prevention and intervention of DPN in patients with T2DM.
Topics: Humans; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Risk Factors; Glycated Hemoglobin; Diabetic Retinopathy
PubMed: 36908480
DOI: 10.3389/fpubh.2023.1128069 -
Medicine Mar 2023Lisfranc and Chopart amputations are historically controversial procedures. To obtain evidence for the pros and cons we performed a systematic review to analyze wound...
BACKGROUND
Lisfranc and Chopart amputations are historically controversial procedures. To obtain evidence for the pros and cons we performed a systematic review to analyze wound healing, the need for re-amputation at a higher level, and ambulation after a Lisfranc or Chopart amputation.
METHODS
A literature search was performed in 4 databases (Cochrane, Embase, Medline, and PsycInfo), using database-specific search strategies. Reference lists were studied to include relevant studies that were missed in the search. Of the 2881 publications found, 16 studies could be included in this review. Excluded publications concerned editorials, reviews, letters to the editor, no full text available, case reports, not meeting the topic, and written in a language other than English, German, or Dutch.
RESULTS
Failed wound healing occurred in 20% after Lisfranc amputation, in 28% after modified Chopart amputation, and 46% after conventional Chopart amputation. After Lisfranc amputation, 85% of patients were able to ambulate without prosthesis for short distances, and after modified Chopart 74%. After a conventional Chopart amputation, 26% (10/38) had unlimited household ambulation.
CONCLUSIONS
The need for re-amputation because wound healing problems occurred most frequently after conventional Chopart amputation. All 3 types of amputation levels do, however, provide a functional residual limb, with the remaining ability to ambulate without prosthesis for short distances. Lisfranc and modified Chopart amputations should be considered before proceeding to a more proximal level of amputation. Further studies are needed to identify patient characteristics to predict favorable outcomes of Lisfranc and Chopart amputations.
Topics: Humans; Foot; Amputation, Surgical; Diabetic Foot; Walking; Artificial Limbs
PubMed: 36897730
DOI: 10.1097/MD.0000000000033188 -
Frontiers in Endocrinology 2023Distal symmetric polyneuropathy (DSPN) is a common microvascular complication of both type 1 and 2 diabetes with substantial morbidity burden and reduced quality of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Distal symmetric polyneuropathy (DSPN) is a common microvascular complication of both type 1 and 2 diabetes with substantial morbidity burden and reduced quality of life. Its association with mortality is equivocal.
PURPOSE
To describe the association between DSPN and all-cause mortality in people with diabetes and further stratify by the type of diabetes based on a meta-analysis of published observational studies.
DATA SOURCES
We searched Medline from inception to May 2021.
STUDY SELECTION
Original data were collected from case-control and cohort studies that reported on diabetes and DSPN status at baseline and all-cause mortality during follow-up.
DATA EXTRACTION
was completed by diabetes specialists with clinical experience in neuropathy assessment.
DATA SYNTHESIS
Data was synthesized using random-effects meta-analysis. The difference between type 1 and 2 diabetes was investigated using meta-regression.
RESULTS
A total of 31 cohorts (n=155,934 participants, median 27.4% with DSPN at baseline, all-cause mortality 12.3%) were included. Diabetes patients with DSPN had an almost twofold mortality (HR: 1.96, 95%CI: 1.68-2.27, I2 = 91.7%), I 91.7%) compared to those without DSPN that was partly explained by baseline risk factors (adjusted HR: 1.60, 95%CI: 1.37-1.87, I 78.86%). The association was stronger in type 1 compared to type 2 diabetes (HR: 2.22, 95%CI: 1.43-3.45). Findings were robust in sensitivity analyses without significant publication bias.
LIMITATIONS
Not all papers reported multiple adjusted estimates. The definition of DSPN was heterogeneous.
CONCLUSIONS
DSPN is associated with an almost twofold risk of death. If this association is causal, targeted therapy for DSPN could improve life expectancy of diabetic patients.
Topics: Humans; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Quality of Life; Risk Factors; Polyneuropathies
PubMed: 36875485
DOI: 10.3389/fendo.2023.1079009 -
Wounds : a Compendium of Clinical... Jan 2023The aim of this review was to investigate the effect of exercise, physical activity, stepping characteristics, and loading on DFU healing. A systematic review using...
The aim of this review was to investigate the effect of exercise, physical activity, stepping characteristics, and loading on DFU healing. A systematic review using proprietary software and a PRISMA 2020 checklist was performed by searching MEDLINE, ProQuest, Scopus, CINAHL, Ovid, and the Cochrane Library for eligible articles from 1960 to December 2020. The primary outcome was time to wound closure. Other outcomes included percentage of DFU healed and time to percentage reduction in DFU. Of the 9 articles included, 6 addressed step activity during the off-loading phase of healing and 3 investigated the addition of NWB exercise on wound healing. Reduced loading via lower daily step activity, less standing duration, and shorter walking bouts in combination with wearing an off-loading device facilitated more rapid wound healing. Exercise seemed to facilitate more rapid healing, as well. Reduced limb loading via daily activity and use of offloading devices improved DFU healing rates. Additional research is necessary to determine the optimal thresholds for exercise, activity, step characteristics, and loading to improve healing outcomes in persons with DFU.
Topics: Humans; Diabetes Mellitus; Diabetic Foot; Walking; Wound Healing; Exercise Therapy
PubMed: 36749703
DOI: 10.25270/wnds/22007 -
Association of arterial stiffness and neuropathy in diabetes: a systematic review and meta-analysis.BMJ Open Diabetes Research & Care Feb 2023Evidence is still emerging on the relationships of arterial stiffness with cardiac autonomic neuropathy (CAN) and peripheral neuropathy (PN). To our knowledge no... (Meta-Analysis)
Meta-Analysis
Evidence is still emerging on the relationships of arterial stiffness with cardiac autonomic neuropathy (CAN) and peripheral neuropathy (PN). To our knowledge no systematic reviews or meta-analyses of these associations have been published. The purpose of our review was to assess the association of arterial stiffness with each type of neuropathy. Medline and Embase were systematically searched for observational studies of arterial stiffness and neuropathy.The systematic review of 60 studies (25 for CAN and 37 for PN), 59 including people with diabetes, showed arterial stiffness overall was higher in people with neuropathy than people without neuropathy. Forty-three studies were included in the meta-analysis. For CAN (19 studies), arterial stiffness was increased in people with neuropathy compared with without, as measured by pulse wave velocity (PWV) (mean difference: 1.32 m/s, 95% CI 0.82 to 1.81, p<0.00001), pulse pressure (PP) (mean difference: 6.25 mmHg, 95% CI 4.51 to 7.99, p<0.00001) or augmentation index (mean difference: 5.52%, 95% CI 3.46 to 7.58, p<0.0001). For PN (26 studies), arterial stiffness was increased in people with neuropathy compared with those without, as measured by PWV (mean difference: 1.22 m/s, 95% CI 0.87 to 1.58, p<0.00001) or PP (mean difference: 4.59 mmHg, 95% CI 2.96 to 6.22, p<0.00001). Only two cohort studies were located so the temporality of the association between arterial stiffness and neuropathy remains unclear. Increased arterial stiffness is associated with CAN and PN.PROSPERO registration number: CRD42019129563.
Topics: Humans; Vascular Stiffness; Pulse Wave Analysis; Diabetes Mellitus; Peripheral Nervous System Diseases; Blood Pressure
PubMed: 36746528
DOI: 10.1136/bmjdrc-2022-003140 -
Frontiers in Endocrinology 2022Diabetic foot ulcerations (DFUs) are a common but highly morbid complication of long-standing diabetes, carrying high rates of associated major amputation and mortality.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetic foot ulcerations (DFUs) are a common but highly morbid complication of long-standing diabetes, carrying high rates of associated major amputation and mortality. Transverse tibial bone transport (TTT) has recently been applied for treatment of DFUs with the aim of accelerating wound healing. This study was performed to evaluate the effectiveness and safety of TTT in patients with DFUs.
METHODS
Two authors independently retrieved the platforms of PubMed, Embase and CENTRAL, to identify studies associated with treatment of DFUs with TTT. Quantitative meta-analyses were performed to pool all available outcomes about the effectiveness and complications of TTT operation, with fixed- (I<50%) or random-effect (I>50%) model according to I.
RESULTS
A total of 7 studies, involving 818 participants, were included, with 661 participants treated with TTT operation. The pooled healing rate and limb salvage rate were 0.96 (95%CI: 0.93~0.98) and 0.98 (95%CI: 0.95~1.00) respectively after treatment with TTT. The pooled mean healing time was 15.03 (95%CI: 9.05~21.00) months. When compared with the pre-operative baseline values, the ankle-brachial index (ABI, MD: 0.23; 95%CI: 0.03~0.44; p<0.001), skin temperature (MD: 1.56; 95%CI: 0.30~2.81; p<0.001), and visual analogue scale (VAS, MD: 3.70; 95%CI: 1.97~5.44; p<0.001) were significantly improved at the final follow-up. When compared with non-TTT group, the TTT group was associated with higher healing rate (OR: 10.43; 95%CI: 3.96~27.43; p<0.001) and limb salvage rate (OR: 9.65; 95%CI: 3.30~28.20; p<0.001). Concerning the complications of the TTT process, the pooled risks of fracture at transportation site and pin-site infection were 0.02 (95%CI: 0.00~0.04) and 0.08 (95%CI: 0.00~0.22), respectively; and the DFU recurrence rate in TTT group was significantly lowered comparing to that of the non-TTT group (RR: 0.18; 95%CI: 0.06~0.49; p=0.001).
CONCLUSIONS
TTT operation was associated with high healing rate and limb salvage rate, and could significantly improve the ABI, skin temperature, and VAS after operation. When compared with the control group, TTT group provided significantly higher healing rate and limb salvage rate. However, TTT operation should be conducted with caution concerning the incidences of fracture at tibia, infection at pin channels and necrosis of skin overlying the anterior tibia.
Topics: Humans; Diabetic Foot; Tibia; Wound Healing; Amputation, Surgical; Fractures, Bone; Diabetes Mellitus
PubMed: 36686461
DOI: 10.3389/fendo.2022.1095361 -
JAMA Network Open Dec 2022Peripheral neuropathies are common conditions and can result in numbness, paresthesia, motor deficits, and pain. There is increasing evidence for the use of biomarkers... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Peripheral neuropathies are common conditions and can result in numbness, paresthesia, motor deficits, and pain. There is increasing evidence for the use of biomarkers as clinical indicators of the presence, severity, and prognosis of nerve lesions; however, biomarker identification has largely been focused on disorders of the central nervous system, and less is known about their role in the peripheral nervous system.
OBJECTIVE
To assess blood-based biomarker concentrations associated with nerve involvement in patients with peripheral neuropathy compared with control participants.
DATA SOURCES
Ovid, MEDLINE, Embase, and CINAHL were searched from inception to September 23, 2021.
STUDY SELECTION
Observational studies reporting on blood biomarkers in patients diagnosed with peripheral neuropathy were included. This review was preregistered on PROSPERO and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Data were abstracted by 1 investigator and independently reviewed by a second.
DATA EXTRACTION AND SYNTHESIS
Data were meta-analyzed when at least 2 studies reported the same biomarker with comparable methodology. Fixed-effects models were used when only 2 studies were included; random-effects models were used when more than 2 studies were included.
MAIN OUTCOMES AND MEASURES
The outcome of interest was concentration of biomarkers.
RESULTS
This review included 36 studies reporting on 4414 participants, including 2113 control participants and 2301 patients with peripheral neuropathy with 13 distinct peripheral neuropathy diagnoses. Diabetic neuropathy was the most common neuropathy diagnosis (13 studies), followed by Charcot-Marie-Tooth disease (6 studies) and Guillain-Barre syndrome (6 studies). Overall, 16 different blood-based biomarkers associated with nerve involvement were evaluated. The most used were neurofilament light chain, S100B, brain-derived neurotrophic factor, and neuron-specific enolase. Patients with peripheral neuropathy demonstrated significantly higher levels of neurofilament light chain compared with controls (standardized mean difference [SMD], 0.93 [95% CI, 0.82 to 1.05]; P < .001). There were no significant differences in levels of S100B (SMD, 1.10 [95% CI, -3.08 to 5.28]; P = .38), brain-derived neurotrophic factor (SMD, -0.52 [95% CI, -2.23 to 1.19]; P = .40), or neuron-specific enolase (SMD, -0.00 [95% CI, -1.99 to 1.98]; P = .10) in patients with peripheral neuropathy compared with control participants.
CONCLUSIONS AND RELEVANCE
The findings of this systematic review and meta-analysis support the use of neurofilament light chain as a blood-based measure associated with the presence of neuronal injury in patients with peripheral neuropathy.
Topics: Humans; Adult; Brain-Derived Neurotrophic Factor; Biomarkers; Diabetic Neuropathies; Prognosis; Pain
PubMed: 36574244
DOI: 10.1001/jamanetworkopen.2022.48593