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As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
The objective of this paper was to investigate erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) in diagnosing pedal osteomyelitis (OM) in patients with and without diabetes, and with and without severe renal impairment (SRI). This was a retrospective cohort study of patients with moderate and severe foot infections. We evaluated three groups: Subjects without diabetes (NDM), subjects with diabetes and without severe renal insufficiency (DM-NSRI), and patients with diabetes and SRI (DM-SRI). SRI was defined as eGFR <30. We evaluated area under the curve (AUC), cutoff point, sensitivity and specificity to characterize the accuracy of ESR and CRP to diagnose OM. A total of 408 patients were included in the analysis. ROC analysis in the NDM group revealed the AUC for ESR was 0.62, with a cutoff value of 46 mm/h (sensitivity, 49.0%; specificity, 76.0%). DM-NSRI subjects showed the AUC for ESR was 0.70 with the cutoff value of 61 mm/h (sensitivity, 68.9%; specificity 61.8%). In DM-SRI, the AUC for ESR was 0.67, with a cutoff value of 119 mm/h (sensitivity, 46.4%; specificity, 82.40%). In the NDM group, the AUC for CRP was 0.55, with a cutoff value of 6.4 mg/dL (sensitivity, 31.3%; specificity, 84.0%). For DM-NSRI, the AUC for CRP was 0.70, with a cutoff value of 8 mg/dL (sensitivity, 49.2%; specificity, 80.6%). In DM-SRI, the AUC for CRP was 0.62, with a cutoff value of 7 mg/dL (sensitivity, 57.1%; specificity, 67.7%). While CRP demonstrated relatively consistent utility, ESR's diagnostic cutoff points diverged significantly. These results highlight the necessity of considering patient-specific factors when interpreting ESR results in the context of OM diagnosis.
Our objective was to evaluate normative data for near-infrared spectroscopy (NIRS) in 110 healthy volunteers by Fitzpatrick skin type (FST) and region of the foot. We obtained measurements of the dorsum and plantar foot using a commercially available device (SnapshotNIR, Kent Imaging, Calgary Canada). On the dorsum of the foot, people with FST6 had significantly lower oxygen saturation compared to FST1-5 (p < 0.001), lower oxyhaemoglobin compared to FST2-5 (p = 0.001), but there was no difference in deoxyhaemoglobin. No differences were found on the plantar foot. When comparing dorsal and plantar foot, there was higher oxyhaemoglobin (0.40 ± 0.09 vs. 0.51 ± 0.12, p < 0.001) and deoxyhaemoglobin (0.16 ± 0.05 vs. 0.21 ± 0.05, p < 0.001) on the plantar foot, but no differences in oxygen saturation (dorsal 70.7 ± 10.8, plantar 70.0 ± 9.5, p = 0.414). In 6.4% of feet, there were black areas, for which no NIRS measurements could be generated. All areas with no data were on the dorsal foot and only found in FST 5–6. People with FST6 had significantly larger areas with no data compared to FST 5 (22.2 cm2 ± 20.4 vs. 1.9 cm2 ± 0.90, p = 0.007). These findings should be considered when using NIRS technology. Skin pigmentation should be evaluated in future NIRS studies.
This systematic review and meta-analysis aimed to evaluate the relationship between body mass index (BMI) and mortality of burn patients. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex, and Scientific Information Database (SID) using keywords extracted from Medical Subject Headings such as “Body mass index”, “Burns” and “Mortality” from the earliest to the April 1, 2023. The quality of the studies included in this systematic review was evaluated using the appraisal tool for cross-sectional studies (AXIS tool). Finally, six articles were included in this systematic review and meta-analysis. A total of 16 154 burn patients participated in six studies. Their mean age was 46.32 (SD = 1.99). Of the participants, 71.7% were males. The mean length of hospitalization was 18.80 (SD = 8.08) days, and the average TBSA in burn patients was 38.32 (SD = 2.79) %. Also, the average BMI in burn patients was 27.10 (SD = 1.75). Results found mortality in patients with abnormal BMI (overweight to morbidity BMI) was 0.19 more than normal BMI (ES: 1.19, 95%CI: 0.76–1.87, Z = 0.75, I 2: 71.8%, p = 0.45). Results of linear dose–response showed each 5 kg/m2 increase in BMI was associated with a 5% increase in mortality that was marginally significant (ES: 1.05, 95%CI: 1.00–1.11, Z = 1.99, I 2: 22.2%, p = 0.047). There was a non-linear relationship between levels of BMI and mortality (Prob > χ 2 = 0.02). There was an increase in mortality from percentile 10 to 50, although it was not significant (Correlational coefficient: 0.01, p = 0.85). Also, there was an increase in mortality rate from percentile 50 to 90 that was statistically significant (correlational coefficient: 0.06, p = 0.047). Finally, the results of the study indicated BMI can increase the chance of mortality by 0.19, although it was not significant. As a result, more studies are needed to better judge the relationship between BMI and mortality in burn victims.
Limb salvage is a difficult path for patients to travel as there is no guarantee of the outcome, often the major factor is perfusion. For patients who underwent transmetatarsal amputation (TMA), success rate is crucial as the next option is most likely a major amputation. We performed a 10 years (2010–2020) retrospective review of patients that underwent a TMA and had an angiogram or computed tomography angiography (CTA) perioperatively at the Dallas VA Medical Center. Failure after TMA was defined as a patient requiring a proximal amputation within 1 year. There were 125 TMAs performed between 2010 and 2020 at the institution. Forty-four (35.2%) patients had an angiogram/CTA peri-operative and met the inclusion criteria. Seventeen subjects (38.6%) had a higher level of amputation. Of the 17 failures, 2 (11.8%) patients had no patent vessel runoff to the foot, 9 (52.9%) had one vessel, 4 (23.5%) had two vessels, and 2 (11.8%) had three vessels runoff. One vessel runoff to the foot yielded a high rate of poor outcomes (56.3%) defined as a higher level of amputation. Two or more vessels runoff to the foot had over 75% success of limb salvage with a TMA.
A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.
FreshRSS 