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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 -
Asian Journal of Surgery Jan 2022The present systematic review and meta-analysis was performed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic foot ulcers... (Meta-Analysis)
Meta-Analysis Review
The present systematic review and meta-analysis was performed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic foot ulcers (DFUs). Relevant articles were retrieved from PubMed, the Cochrane Library, EMBASE and other databases through November 2020. A total of 20 randomized clinical trials and 1263 trials were included in the meta-analysis. For each trial, the average difference, odds ratio and 95% confidence interval were calculated to evaluate the efficacy. Hyperbaric oxygen therapy increased the healing rate of diabetic foot ulcers (relative risk, 1.901; 95% CI = 1.484-2.435, p < 0.0001), shortened the healing time (MD = -19.360; 95% CI = -28.753~-9.966, p < 0.001), and reduced the incidence of major amputation (relative risk, 0.518, 95% CI = 0.323-0.830, P < 0.01). In summary, our meta-analysis confirmed that hyperbaric oxygen therapy offers great benefits in the treatment of DFU and the reduction of amputation. In addition, larger and well-designed randomized controlled trials need to be planned and conducted to verify this conclusion.
Topics: Amputation, Surgical; Diabetes Mellitus; Diabetic Foot; Humans; Hyperbaric Oxygenation; Risk; Wound Healing
PubMed: 34376365
DOI: 10.1016/j.asjsur.2021.07.047 -
PloS One 2020Phantom limb pain (PLP)-pain felt in the amputated limb-is often accompanied by significant suffering. Estimates of the burden of PLP have provided conflicting data. To... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Phantom limb pain (PLP)-pain felt in the amputated limb-is often accompanied by significant suffering. Estimates of the burden of PLP have provided conflicting data. To obtain a robust estimate of the burden of PLP, we gathered and critically appraised the literature on the prevalence and risk factors associated with PLP in people with limb amputations.
METHODS
Articles published between 1980 and July 2019 were identified through a systematic search of the following electronic databases: MEDLINE/PubMed, PsycINFO, PsycArticles, Cumulative Index to Nursing and Allied Health Literature, Africa-Wide Information, Health Source: Nursing/Academic Edition, SCOPUS, Web of Science and Academic Search Premier. Grey literature was searched on databases for preprints. Two reviewers independently conducted the screening of articles, data extraction and risk of bias assessment. The meta-analyses were conducted using the random effects model. A statistically significant level for the analyses was set at p<0.05.
RESULTS
The pooling of all studies demonstrated a prevalence estimate of 64% [95% CI: 60.01-68.05] with high heterogeneity [I2 = 95.95% (95% CI: 95.10-96.60)]. The prevalence of PLP was significantly lower in developing countries compared to developed countries [53.98% vs 66.55%; p = 0.03]. Persistent pre-operative pain, proximal site of amputation, stump pain, lower limb amputation and phantom sensations were identified as risk factors for PLP.
CONCLUSION
This systematic review and meta-analysis estimates that six of every 10 people with an amputation report PLP-a high and important prevalence of PLP. Healthcare professionals ought to be aware of the high rates of PLP and implement strategies to reduce PLP by addressing known risk factors, specifically those identified by the current study.
Topics: Amputation, Surgical; Clinical Decision-Making; Humans; Phantom Limb; Prevalence; Risk Factors
PubMed: 33052924
DOI: 10.1371/journal.pone.0240431 -
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 -
BMJ Open Feb 2019To estimate the association between the use of sodium glucose co-transporter-2 (SGLT2) inhibitors and postmarket harms as identified by drug regulatory agencies. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To estimate the association between the use of sodium glucose co-transporter-2 (SGLT2) inhibitors and postmarket harms as identified by drug regulatory agencies.
DESIGN
We conducted a systematic review and meta-analysis of randomised controlled trials (RCT). Six large databases were searched from inception to May 2018. Random effects models were used to estimate pooled relative risks (RRs).
INTERVENTION
SGLT2 inhibitors, compared with placebo or active comparators.
PRIMARY OUTCOMES
Acute kidney injury (AKI), diabetic ketoacidosis (DKA), urinary tract infections (UTI), bone fractures and lower limb amputations.
RESULTS
We screened 2418 citations of which 109 were included. Most studies included one of four SGLT2 inhibitors, dapagliflozin, canagliflozin, empagliflozin and ipragliflozin. When compared with placebo, SGLT2 inhibitors were found to be significantly protective against AKI (RR=0.59; 95% CI 0.39 to 0.89; I=0.0%), while no difference was found for DKA (RR 0.66; 95% CI 0.30 to 1.45, I=0.0%), UTI (RR 1.02; 95% CI 0.95 to 1.09, I=0.0%) or bone fracture (RR 0.87; 95% CI 0.69 to 1.09, I=1.3%). Three studies reported on amputation, with one finding a significant increase risk. No increased risk for either outcome was found when compared with active controls. Subgroup analysis did show an increased risk of UTI with dapagliflozin only (RR 1.21; 95% CI 1.02 to 1.43, I=0.0%), but no other analysis supported an increased risk of AKI, DKA, UTI or fracture.
CONCLUSIONS
Current evidence from RCTs does not suggest an increased risk of harm with SGLT2 inhibitors as a class over placebo or active comparators with respect to AKI, DKA, UTI or fracture. However, wide CIs for many comparisons suggest limited precision, and therefore clinically important adverse events cannot be ruled out. Dapagliflozin, appears to independently increase the risk of UTI, although the mechanism for this intraclass variation in risk is unclear.
PROSPERO REGISTRATION NUMBER
CRD42016038715.
Topics: Acute Kidney Injury; Amputation, Surgical; Benzhydryl Compounds; Canagliflozin; Diabetic Ketoacidosis; Fractures, Bone; Glucosides; Humans; Randomized Controlled Trials as Topic; Sodium-Glucose Transporter 2 Inhibitors; Thiophenes; Urinary Tract Infections
PubMed: 30813108
DOI: 10.1136/bmjopen-2018-022577 -
The Journal of Foot and Ankle Surgery :... 2016Transmetatarsal amputations have generally been accepted as a relatively more definitive amputation compared with other lesser ray resections. However, many... (Meta-Analysis)
Meta-Analysis Review
Transmetatarsal amputations have generally been accepted as a relatively more definitive amputation compared with other lesser ray resections. However, many investigators have reported a high occurrence of more proximal amputation after transmetatarsal amputation. A systematic review was performed to evaluate the occurrence of reamputation and reoperation after transmetatarsal amputations. A search of the Medline, CINAHL, and Cochrane Central databases yielded 159 abstracts. After review, 24 reports were included in the study. A total of 391 (26.9%) reoperations were identified after 1453 transmetatarsal amputations. Any level reamputation occurred in 152 (29.7%) of 365 transmetatarsal amputations and major amputation occurred in 380 (33.2%) of 1146 transmetatarsal amputations. Using a random effects model, the reoperation rate was estimated at 24.43% (95% confidence interval 11.64% to 37.21%), the reamputation rate was estimated at 28.37% (95% confidence interval 19.56% to 37.19%), and the major amputation rate was estimated at 30.16% (95% confidence interval 23.86% to 36.47%). These findings raise questions about the conventional wisdom of performing primary transmetatarsal amputation in lieu of other minor amputations, such as partial first ray amputation, and suggest that the choice between transmetatarsal amputation and other minor amputations might be a decision that depends on very patient-specific factors.
Topics: Aged; Amputation, Surgical; Diabetic Foot; Female; Humans; Male; Metatarsal Bones; Middle Aged; Prognosis; Reoperation; Risk Assessment; Severity of Illness Index; Wound Healing
PubMed: 27475711
DOI: 10.1053/j.jfas.2016.05.011 -
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 -
Archives of Cardiovascular Diseases 2023Recently, increased risk of amputation under sodium glucose cotransporter-2 inhibitors has been debated. Similar concerns have been raised with other "traditional"... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recently, increased risk of amputation under sodium glucose cotransporter-2 inhibitors has been debated. Similar concerns have been raised with other "traditional" diuretics, more particularly in patients with or at risk of lower extremity arterial disease (LEAD).
AIM
To collect all available data on any potential risk of amputation associated with diuretics in patients with or at risk of LEAD. Additionally, we looked for other limb-related events in these patients.
METHODS
We searched in PubMed, Embase and Scopus databases up to February 2021 for references, using peripheral or lower extremity arterial disease, diuretics and amputation keywords, excluding case reports, experimental animal studies and non-English reports.
RESULTS
Among the 1376 hits identified in the databases, six studies were finally included in this review, including one cross-sectional and five longitudinal studies (total of 47,612 participants). One study was limited to thiazide diuretics, one focused on loop diuretics and the remainder mixed all diuretics. All studies reported a significant association between diuretic use and amputation risk in patients with or at high risk of LEAD. Despite some limitations in several studies, the meta-analysis showed an increased risk of amputation associated with diuretics (odds ratio: 1.75, 95% confidence interval: 1.53-1.99; P<0.001). Beyond amputation, patients with or at risk of LEAD under diuretics appeared to be at increased risk of other lower limb events, mostly in the presence of other comorbidities, including diabetes.
CONCLUSIONS
Although the amount of data in the literature is scarce, this first systematic review and meta-analysis favours an increased risk of amputation in patients with or at risk of LEAD under diuretics. Further prospective studies must be conducted to provide a better understanding of the mechanisms. Meanwhile, the use of diuretics in these patients should be parsimonious, considering alternatives whenever possible.
Topics: Humans; Diuretics; Cross-Sectional Studies; Peripheral Arterial Disease; Lower Extremity; Amputation, Surgical; Risk Factors
PubMed: 37150644
DOI: 10.1016/j.acvd.2023.04.002 -
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