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Diabetes, Obesity & Metabolism Jun 2024
Meta-Analysis
Risk of lower extremity amputation in patients with type 2 diabetes mellitus and peripheral arterial disease receiving sodium-glucose cotransporter-2 inhibitors versus other medications: A systematic review and meta-analysis of observational cohort studies.
Topics: Humans; Sodium-Glucose Transporter 2 Inhibitors; Diabetes Mellitus, Type 2; Amputation, Surgical; Peripheral Arterial Disease; Observational Studies as Topic; Lower Extremity; Diabetic Foot; Hypoglycemic Agents; Diabetic Angiopathies; Male
PubMed: 38558251
DOI: 10.1111/dom.15571 -
The International Journal of Lower... Mar 2024The skin, as the body's largest organ, plays vital roles in sensory functions, temperature regulation, and protection against pathogens and injuries. Skin wounds, which... (Review)
Review
AIMS
The skin, as the body's largest organ, plays vital roles in sensory functions, temperature regulation, and protection against pathogens and injuries. Skin wounds, which disrupt its integrity, can result from various factors, including diseases such as diabetes. Diabetic foot ulcers are a severe complication of diabetes, often leading to amputations. This systematic review explores the therapeutic potential of silver nanoparticles in the management of diabetic ulcers.
METHODS
Seven studies published between 2016 and 2023 were included in this review. Also, 4 studies were included in the meta-analysis. These studies investigated the application of silver nanoparticles, primarily in dressing forms, for diabetic ulcer treatment. A systematic search strategy was employed, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed.
RESULTS
The results show that silver nanoparticles do not have a significant difference in improving DFU healing rates. SilvrSTAT Gel, a dressing containing silver nanoparticles, outperformed traditional dressings, leading to a substantial percentage of ulcers healing within weeks. Comparative studies also indicated that silver nanoparticles were at least as effective as alternative treatments, such as nano-chitosan dressings, and showed potential for combination therapy with growth factors.
DISCUSSION
This review underscores the promise of silver nanoparticles, a nanotechnology-based approach, in accelerating the healing of diabetic ulcers while providing antimicrobial benefits. Despite some limitations, including variations in treatment regimens and a lack of long-term outcome data, these findings show there is no clinical evidence for using Nanosilver for the healing process of DFU.
CONCLUSION
Silver nanoparticles currently do not have sufficient clinical evidence for healing the DFU; however, in some studies, they had noticeable effects on the rate of wound healing.
PubMed: 38544426
DOI: 10.1177/15347346241241836 -
BMC Musculoskeletal Disorders Mar 2024There are many consequences of lower limb amputation, including altered biomechanics of gait. It has previously been shown that these can lead to increased rates of... (Review)
Review
BACKGROUND
There are many consequences of lower limb amputation, including altered biomechanics of gait. It has previously been shown that these can lead to increased rates of osteoarthritis (OA). A common and successful treatment for severe OA is joint replacement. However, it is unclear whether amputees undergoing this surgery can expect the same outcomes or complication profile compared with non-amputees. Furthermore, there are key technical challenges associated with hip or knee replacement in lower limb amputees. This scoping review aimed to identify and summarise the existing evidence base.
METHODS
This was a systematic scoping review performed according to PRISMA guidelines. An electronic database search of MEDLINE (PubMed), Cochrane Library, EMBASE and CINAHL was completed from the date of inception to 1 April 2023. All peer reviewed literature related to hip or knee replacement among lower limb amputees was included.
RESULTS
Of the 931 records identified, 40 studies were included in this study. The available literature consisted primarily of case reports and case series, with generally low level of evidence. In total, there were 265 patients of which 195 received total hip replacement (THR), 51 received total knee replacement (TKR) and 21 received hip hemiarthroplasty. The most common reason for amputation was trauma (34.2%), and the main indication for joint replacement was OA (77.1%), occurring more frequently in the contralateral limb (66.7%). The outcomes reported varied widely between studies, with most suggesting good functional status post-operatively. A variety of technical tips were reported, primarily concerned with intra-operative control of the residual limb.
CONCLUSION
There is a need for more observational studies to clearly define the association between amputation and subsequent need for joint replacement. Furthermore, comparative studies are needed to identify whether amputees can be expected to achieve similar functional outcomes after surgery, and if they are at higher risk of certain complications.
Topics: Humans; Arthroplasty, Replacement, Knee; Amputees; Lower Extremity; Osteoarthritis; Arthroplasty, Replacement, Hip
PubMed: 38539152
DOI: 10.1186/s12891-024-07342-z -
Plastic and Reconstructive Surgery.... Mar 2024Diabetic foot ulcers (DFUs) are common complications of uncontrolled diabetes mellitus that can result in infection and amputation of the lower extremities. This study...
BACKGROUND
Diabetic foot ulcers (DFUs) are common complications of uncontrolled diabetes mellitus that can result in infection and amputation of the lower extremities. This study compared the benefits and risks of hyperbaric oxygen therapy with those of other DFU treatments, based on the Wagner grading system.
METHODS
Systematic searches for randomly controlled trials using hyperbaric oxygen therapy for DFUs were performed using PubMed, the Cochrane Library, and Embase. Data regarding demographics, wound healing, minor and major amputations, operative debridement, nonhealing wounds, and adverse effects were analyzed based on Wagner grades, using RevMan 5.4.1 and Microsoft Excel.
RESULTS
Hyperbaric oxygen therapy was significantly superior to other treatments for wound healing rates 8 or more weeks after the final treatment (RR = 2.39; 1.87-3.05; < 0.00001) minor/distal amputations (RR = 0.58; 0.43-0.80; < 0.007), and major/proximal amputations (RR = 0.31; 0.18-0.52; < 0.00001) for the 14 studies analyzed. In addition, this therapy increased the rate of complete wound healing for Wagner grades II (RR = 21.11; 3.05-146.03; = 0.002), III (RR = 19.58; 2.82-135.94, = 0.003), and IV (RR = 17.53; 2.45-125.44; = 0.004); decreased the minor/distal amputation rate for grade III (RR = 0.06; 0.01-0.29; = 0.0004) and the major/proximal amputation rate on for grade IV (RR = 0.08; 0.03-0.25; < 0.0001); and decreased the operative debridement rate for Wagner grade II (RR = 0.09; 0.01-0.60; = 0.01).
CONCLUSIONS
Moderate-quality evidence revealed that adjunctive hyperbaric oxygen therapy improved DFU wound healing for Wagner grades II, III, and IV; prevented minor and major amputations for grades III and IV, respectively; and prevented operative debridement in grade II wounds.
PubMed: 38528847
DOI: 10.1097/GOX.0000000000005692 -
Journal of Burn Care & Research :... Mar 2024There is no consensus for the optimal management of diabetic foot burn injuries. Here, we systematically identify studies reporting on diabetic foot burns and evaluate...
There is no consensus for the optimal management of diabetic foot burn injuries. Here, we systematically identify studies reporting on diabetic foot burns and evaluate outcomes among patients managed operatively versus non-operatively. PubMed, Embase, and Web of Science were searched. Screening was performed by independent reviewers. Primary research studies with English full texts published between 1980 to 2023 that discussed outcomes of foot burns in adults with diabetes were included and critically appraised using validated tools. Results are presented using descriptive statistics of aggregated data. The search yielded 2,402 non-duplicate papers, of which 35 met inclusion criteria. Nine papers were included for meta-analysis, including seven retrospective comparative analyses, one cross-sectional study, and one retrospective chart review. There were 1798 diabetic foot burn patients. Mean age was 58.2 years (SD 4.12) and 73.1% (n = 1,314) were male. A total of 15.7% (n = 283) of patients were surgically managed, including debridement (3.7%, n = 66), grafting (8.2%, n = 147), flap (0.2%, n = 3), and primary amputation (7.1%, n = 127). Secondary amputation rate, defined as amputation following initial surgery, was 4.9%, (n = 14). The overall amputation rate was 7.8% (n = 141). Other complications included infection (4.0%, n = 72), osteomyelitis (1.9%, n = 34), and graft failure (8.2%, n = 12). One study reported functional status at last visit. Diabetic foot burns are highly morbid. The surgical management of these complex injuries is high risk, as amputation results in poorer quality of life and functional outcomes.
PubMed: 38520367
DOI: 10.1093/jbcr/irae051 -
Prosthetics and Orthotics International Mar 2024Chronic pain following amputation is debilitating. Due to its mechanisms in modulating muscle contraction and pain, botulinum toxin has been investigated as a treatment...
Chronic pain following amputation is debilitating. Due to its mechanisms in modulating muscle contraction and pain, botulinum toxin has been investigated as a treatment option for phantom limb pain (PLP) and residual limb pain (RLP). The objective of this study was to determine the efficacy of botulinum toxin injection in the management of PLP and RLP following major limb amputation using a systematic review of the literature. The databases Medline, CINAHL, EMBASE, Scopus, Web of Science, and Cochrane were searched from inception through October 30, 2023. The search identified 50 articles; 37 underwent full-text review, and 11 were included in the final review. Eighty-nine individuals with pain were investigated by the included studies; 53 had RLP and 63 had PLP. There was significant variation in botulinum toxin type, injection method, and dosage. Twenty-one (53.9%) and 27 (64.3%) participants had improvement in PLP and RLP following botulinum toxin injection, respectively. Therefore, there is potential for use of botulinum toxin for the treatment of PLP and RLP. However, due to the minimal number of studies, small sample sizes, and heterogenous methodologies, our ability to conclude with certainty the efficacy of botulinum toxin injection on the treatment of PLP and RLP following amputation is limited.
PubMed: 38517393
DOI: 10.1097/PXR.0000000000000344 -
Diving and Hyperbaric Medicine Mar 2024There are inconsistencies in outcome reporting for patients with necrotising soft tissue infections (NSTI). The aim of this study was to evaluate reported outcome... (Review)
Review
INTRODUCTION
There are inconsistencies in outcome reporting for patients with necrotising soft tissue infections (NSTI). The aim of this study was to evaluate reported outcome measures in NSTI literature that could inform a core outcome set (COS) such as could be used in a study of hyperbaric oxygen in this indication.
METHODS
A systematic review of all NSTI literature identified from Cochrane, Ovid MEDLINE and Scopus databases as well as grey literature sources OpenGrey and the New York Academy of Medicine databases which met inclusion criteria and were published between 2010 and 2020 was performed. Studies were included if they reported on > 5 cases and presented clinical endpoints, patient related outcomes, or resource utilisation in NSTI patients. Studies did not have to include intervention. Two independent researchers then extracted reported outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. An attempt was made to identify trends in outcome measures over time and by study design.
RESULTS
Three hundred and seventy-five studies were identified and included a total of 311 outcome measures. Forty eight percent (150/311) of outcome measures were reported by two or more studies. The four most frequently reported outcome measures were mortality without time specified, length of hospital stay, amputation performed, and number of debridements, reported in 298 (79.5%), 260 (69.3%), 156 (41.6%) and 151 (40.3%) studies respectively. Mortality outcomes were reported in 23 different ways. Randomised controlled trials (RCTs) were more likely to report 28-day mortality or 90-day mortality. The second most frequent amputation related outcome was level of amputation, reported in 7.5% (28/375) of studies. The most commonly reported patient-centred outcome was the SF-36 which was reported in 1.6% (6/375) of all studies and in 2/10 RCTs.
CONCLUSIONS
There was wide variance in outcome measures in NSTI studies, further highlighting the need for a COS.
Topics: Humans; Soft Tissue Infections; Outcome Assessment, Health Care; Oxygen; Patient Reported Outcome Measures
PubMed: 38507909
DOI: 10.28920/dhm54.1.47-56 -
World Journal of Emergency Surgery :... Mar 2024Tourniquets (TQ) have been increasingly adopted in pre-hospital settings recently. This study examined the effectiveness and safety of applying TQ in the pre-hospital... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tourniquets (TQ) have been increasingly adopted in pre-hospital settings recently. This study examined the effectiveness and safety of applying TQ in the pre-hospital settings for civilian patients with traumatic vascular injuries to the extremities.
MATERIALS AND METHODS
We systematically searched the Ovid Embase, PubMed, and Cochrane Central Register of Controlled Trials databases from their inception to June 2023. We compared pre-hospital TQ (PH-TQ) use to no PH-TQ, defined as a TQ applied after hospital arrival or no TQ use at all, for civilian vascular extremity trauma patients. The primary outcome was overall mortality rate, and the secondary outcomes were blood product use and hospital stay. We analyzed TQ-related complications as safety outcomes. We tried to include randomized controlled trials (RCTs) and non-randomized studies (including non-RCTs, interrupted time series, controlled before-and-after studies, cohort studies, and case-control studies), if available. Pooled odds ratios (ORs) were calculated and the certainty of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology.
RESULTS
Seven studies involving 4,095 patients were included. In the primary outcome, pre-hospital TQ (PH-TQ) use significantly decrease mortality rate in patients with extremity trauma (odds ratio [OR], 0.48, 95% confidence interval [CI] 0.27-0.86, I = 47%). Moreover, the use of PH-TQ showed the decreasing trend of utilization of blood products, such as packed red blood cells (mean difference [MD]: -2.1 [unit], 95% CI: -5.0 to 0.8, I = 99%) or fresh frozen plasma (MD: -1.0 [unit], 95% CI: -4.0 to 2.0, I = 98%); however, both are not statistically significant. No significant differences were observed in the lengths of hospital and intensive care unit stays. For the safety outcomes, PH-TQ use did not significantly increase risk of amputation (OR: 0.85, 95% CI: 0.43 to 1.68, I = 60%) or compartment syndrome (OR: 0.94, 95% CI: 0.37 to 2.35, I = 0%). The certainty of the evidence was very low across all outcomes.
CONCLUSION
The current data suggest that, in the pre-hospital settings, PH-TQ use for civilian patients with vascular traumatic injury of the extremities decreased mortality and tended to decrease blood transfusions. This did not increase the risk of amputation or compartment syndrome significantly.
Topics: Humans; Vascular System Injuries; Hemorrhage; Tourniquets; Hospitals; Extremities; Compartment Syndromes
PubMed: 38504263
DOI: 10.1186/s13017-024-00536-9 -
Wound Repair and Regeneration :... Mar 2024Diabetic foot ulcers are a common and severe complication of diabetes mellitus, and a risk factor for amputation. Because of the vessel insufficiency in diabetic foot... (Review)
Review
Diabetic foot ulcers are a common and severe complication of diabetes mellitus, and a risk factor for amputation. Because of the vessel insufficiency in diabetic foot ulcers (DFU), vascular endothelial growth factor (VEGF) that simulates angiogenesis is of interest to promote wound healing. This systematic review evaluates the last 16 years of in-vivo studies with VEGF stimulation as a treatment for DFU, developed based on the last published systematic article. A total of 961 articles were identified through databases in two phases. 947 articles were excluded by exclusion criteria, and four articles met our inclusion criteria and were included. The effects of VEGF on wound healing were analysed in all four studies. In three studies, the VEGF-treated wounds showed statistically faster healing than those not treated with VEGF. In one study, the VEGF-treated wounds revealed a positive trend toward faster healing. Furthermore, all four studies were in favor of using VEGF, but concluded that further research is needed. These studies showed a positive trend towards faster healing and was safe when using VEGF topically on humans. Furthermore, viral particles of VEGF seem to have a systematic effect when a dose exceeding 5.0 × 10 vp pr wound. Future research in using VEGF on DFU should focus on VEGF's relevant dosage, release rate, and specific mechanism. This review inspires further research, and a consistent study design is prerequisite such that results are more homogenic and comparable. Much effort is needed to translate the results into our clinical practice.
PubMed: 38494793
DOI: 10.1111/wrr.13171 -
The Journal of Clinical Endocrinology... Mar 2024Diabetes mellitus is associated with morbid complications such as diabetic foot ulcers (DFUs) that may lead to amputations or mortality if not managed adequately.
CONTEXT
Diabetes mellitus is associated with morbid complications such as diabetic foot ulcers (DFUs) that may lead to amputations or mortality if not managed adequately.
OBJECTIVE
New adjunctive interventions to treat diabetic wounds include topical biologics and growth factors. This study aims to evaluate their efficacy in improving wound healing outcomes and safety.
DATA SOURCES
Comprehensive database searches of MEDLINE via PubMed, EMBASE and Cochrane performed from inception to December 2022.
STUDY SELECTION
Three independent researchers selected the studies. Randomised-controlled trials that compared the use of a topical biologic growth factor-containing regimen to other biologics or standard of care (SOC) were included.
DATA EXTRACTION AND SYNTHESIS
This review followed PRISMA guidelines. Risk of bias analysis was performed using the Jadad scale. Network meta-analysis was performed. Treatments were grouped into common nodes based on the type of biologic agent.
MAIN OUTCOMES AND MEASURES
Primary outcomes of interest were healing rate and time to wound closure. Secondary outcomes included wound infection, serious adverse events, and amputation rate.
RESULTS
Human umbilical cord (HUC) was associated with the highest cure, followed by recombinant human epidermal growth factor (hEGF). A significantly greater reduction in the time to cure DFUs was seen in HUC, hEGF and fibroblast growth factor (FGF). There was a significantly lower risk of adverse events (AEs) when platelet-rich plasma (PRP) was administered.
CONCLUSION
HUC, hEGF and FGF are promising topical biologics with statistically significant primary outcomes compared to SOC, while PRP is effective in reducing ulcer-related AEs. HUC has been found to be the most effective in terms of cure rate and a reduction in time to cure.
PubMed: 38477463
DOI: 10.1210/clinem/dgae128