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The meta-analysis aimed to assess the effect of hyperbaric oxygen treatment on diabetic foot ulcers. Using dichotomous or contentious random or fixed effect models, the outcomes of this meta-analysis were examined and the odds ratio (OR) and the mean difference (MD) with 95% confidence intervals (CIs) were computed. 17 examinations from 1992 to 2022 were enrolled for the present meta-analysis, including 7219 people with diabetic foot ulcers. Hyperbaric oxygen treatment had a significantly higher healed ulcer (OR, 14.39; 95% CI, 4.02–51.52, p < 0.001), higher adverse event (OR, 2.14; 95% CI, 1.11–4.11, p = 0.02), lower mortality (OR, 0.22; 95% CI, 0.07–0.71, p = 0.01) and higher ulcer area reduction (MD, 23.39; 95% CI, 11.79–34.99, p < 0.001) compared to standard treatment in patients with diabetic foot ulcers. However, hyperbaric oxygen treatment and standard treatment had no significant difference in amputation (OR, 0.62; 95% CI, 0.22–1.75, p = 0.37), major amputation (OR, 0.59; 95% CI, 0.18–1.92, p = 0.38), minor amputation (OR, 0.64; 95% CI, 0.15–2.66, p = 0.54) and healing time (MD, −0.001; 95% CI, −0.76 to 0.75, p = 0.99) in patients with diabetic foot ulcers. The examined data revealed that hyperbaric oxygen treatment had a significantly higher healed ulcer, adverse event, and ulcer area reduction and lower mortality, however, there was no significant difference in amputation and healing time compared to standard treatment in patients with diabetic foot ulcers. Yet, attention should be paid to its values since most of the selected examinations had a low sample size and some of the comparisons had a low number of selected studies.
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.
To investigate the effectiveness of antimicrobial agents against wound infections, experiments using either 2D cultures with planktonic microorganisms or animal infection models are frequently carried out. However, the transferability of the results to human skin is limited by the lack of complexity of the 2D models or by the poor translation of the results from animal models. Hence, there is a need for wound infection models capable of assessing antimicrobial agents. In this study, an easily standardized wound infection model was established. This model consists of a mechanically wounded human skin model on a collagen matrix infected with various clinically relevant bacteria. Infection of the model led to recognition of the pathogens and induction of an inflammatory response. The untreated infection spread over time, causing significant tissue damage. By applying an antimicrobial-releasing wound dressing, the bacterial load could be reduced and the success of the treatment could be further measured by a decrease in the inflammatory reaction. In conclusion, this wound infection model can be used to evaluate new antimicrobial therapeutics as well as to study host-pathogen interactions.
This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).
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