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Background Venous leg ulcers are slow-healing wounds with a high recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with regards to therapeutic measures and have difficulties with adherence to treatment protocols. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial. Method/Design First, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients ( n = 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12 weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data. Discussion We will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole. Trial registration ClinicalTrials.gov, NCT03454698 . Registered on 6 March 2018.

Even with the best available care, at least 25% of leg ulcers and foot ulcers are not fully healed after 6 months of treatment. This review summarizes the pathophysiological features and explains current management of venous, arterial, neuropathic diabetic, and pressure ulcers.

Background Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia. Methods A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results. Results Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings. Conclusions This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.

Objective To determine the effect of low dose aspirin on ulcer healing in patients with venous leg ulcers.Design Pragmatic, community based, parallel group, double blind, randomised controlled trial.Setting Five community nursing centres in New Zealand.Participants 251 adults with venous leg ulcers who could safely be treated with aspirin or placebo: 125 were randomised to aspirin and 126 to placebo.Interventions 150 mg oral aspirin daily or matching placebo for up to 24 weeks treatment, with compression therapy as standard background treatment.Main outcome measures The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one ulcer was present). Secondary outcomes included proportion of participants healed, change in ulcer area, change in health related quality of life, and adverse events. Analysis was by intention to treat.Results The median number of days to healing of the reference ulcer was 77 in the aspirin group and 69 in the placebo group (hazard ratio 0.85, 95% confidence interval 0.64 to 1.13, P=0.25). The number of participants healed at the endpoint was 88 (70%) in the aspirin group and 101 (80%) in the placebo group (risk difference −9.8%, 95% confidence interval −20.4% to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm2 in the aspirin group and 4.8 cm2 in the placebo group (mean difference −0.7 cm2, 95% confidence interval −1.9 to 0.5 cm2, P=0.25). 40 adverse events occurred among 29 participants in the aspirin group and 37 adverse events among 27 participants in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7, P=0.71).Conclusion Our findings do not support the use of low dose aspirin as adjuvant treatment for venous leg ulcers.Trial registration ClinicalTrials.gov NCT02158806.

Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

Antiphospholipid antibody (aPL)-induced activation of the mTOR (mammalian target of rapamycin) signaling pathway in endothelial cells plays a role in the pathogenesis of vascular lesions in antiphospholipid syndrome (APS). However, there are no data on whether this mechanism also contributes to the development of skin ulcers commonly observed in APS. We investigated the activation of mTOR in skin specimens from aPL-positive and aPL-negative patients with leg ulcers. Patients with leg ulcers who had primary or secondary APS or no detectable aPLs were included in the study. Biopsies were taken from the ulcer edges and the adjacent non-ulcerated skin areas. Activation of mTORC1 (mTOR Complex1) and mTORC2 (mTOR Complex2) in endothelial cells was determined by immunohistochemical analysis of phosphorylated ribosomal S6 protein (pS6RP) and phosphorylated protein kinase B (pAKT), respectively. In all aPL-positive patients, regardless of whether they had primary or secondary APS, we found a positive immunohistochemical reaction to pS6RP (mTORC1 activation) in the endothelial cells of the ulcer samples. On the other hand, pS6RP could not be detected in samples from aPL-negative chronic venous ulcers. Furthermore, pS6RP was not present in samples taken from the unaffected skin adjacent to the ulcers in aPL-positive patients. The pAKT reaction (mTORC2) was negative in both aPL-positive and aPL-negative patients, both in the ulcers and in the periulcer skin. Activation of the mTOR pathway may contribute to ulcer development in APS. The mTORC1 may be a target for therapeutic modification in APS-associated skin ulcers.

Leg ulcers are a very serious worldwide medical problem. When the ulcer is extensive and deep the prognosis is usually unfavorable. The treatment requires comprehensive solutions that take into account modern specialized medical dressings, and more and more often, selected methods in the field of physical medicine. The study included 30 patients (13 women—43.4% and 17 men—56.6%) with chronic arterial ulcers of the lower limbs. The mean age of the treated patients was 65.63 ± 8.77 years. Patients were randomly assigned to two study groups. In group 1 (16 patients), specialist ATRAUMAN Ag medical dressings and local hyperbaric oxygen therapy treatments were used. In group 2 (14 patients), only specialized ATRAUMAN Ag dressings were used. The treatment was carried out for 4 weeks. The progress of healing ulcers was assessed by using the planimetric method, while the intensity of pain ailments was assessed by the visual analog VAS scale. In both study groups, a statistically significant reduction in the mean surface area of the treated ulcers was obtained, respectively, from 8.53 ± 1.71 cm2 to 5.55 ± 1.11 cm2 in group 1 (p < 0.001) and 8.43 ± 1.51 cm2 to 6.28 ± 1.13 cm2 in group 2 (p < 0.001). There was also a statistically significant reduction in the intensity of pain ailments, respectively: 7.93 ± 0.68 points to 5.00 ± 0.63 points in group 1 (p < 0.001) and 8.00 ± 0.67 points to 5.64 ± 0.49 points in group 2 (p < 0.001). The percentage change in ulcer area from baseline in group 1 was 34.6 ± 8.47% and was statistically significantly greater than in group 2 (25.23 ± 6.01%) (p = 0.003). In turn, the percentage assessment of the pain intensity assessed in the VAS scale in group 1 was 36.97 ± 6.36% and was statistically significantly higher compared to group 2 (29.34 ± 4.77%) (p = 0.002). The addition of local hyperbaric oxygen therapy treatments as a supplement to the therapy with the use of specialized medical dressings improves the effectiveness the arterial ulcers treatment of the lower limbs in terms of reducing the ulceration area and reducing pain ailments.

The objective of this study is to evaluate the antimicrobial activity and healing-promoting effect of topical photodynamic therapy (ALA-PDT) on chronic skin ulcers infected with Pseudomonas aeruginosa (PA). A total of 26 patients with chronic skin ulcers in lower limbs infected with PA were enrolled. The surface areas of the ulcers were treated with either δ-aminolevulinic acid (ALA)-mediated PDT (20 % ALA solution, 1.5 h incubation, 630 nm red light, 80 J/cm 2 ) or red light alone, both once a week for two weeks. Before treatment, the wound areas and the bacteria levels in these two groups were comparable ( p  > 0.05). Results indicated that the bacteria levels in the skin ulcers of the light only group of 24 h post-treatment (3.4 × 10 7  ± 7.1 × 10 7  CFU/cm 2 ) and pre-treatment (5.5 × 10 7  ± 1.6 × 10 8  CFU/cm 2 ) were not significantly different. In contrast, the bacteria levels on the surfaces of the ulcers in the PDT group of 24 h post-treatment (6.3 × 10 5  ± 1.7 × 10 6  CFU/cm 2 ) and pre-treatment (8.9 × 10 7  ± 1.7 × 10 8  CFU/cm 2 ) were significantly different ( p  < 0.01). At seven days post treatment, the mean ulcer area in the red light group was reduced from 11.85 ± 6.83 to 7.8 ± 4.9 cm 2 ( p  < 0.01), that of PDT group from 12.72 ± 8.58 to 3.4 ± 3.4 cm 2 ( p  < 0.01). Better healing was seen in PDT group ( p  < 0.01). In conclusion, ALA-PDT is a potential modality to control PA infection and promote healing of chronic skin ulcers in lower limbs.

Chronic wounds pose significant challenges to patients and potentially reduce patients' quality of life. A prospective randomised control trial (RCT) was conducted in Russia between 2018 and 2021 to assess the effectiveness of treating chronic wounds with a high‐intensity Erbium: Yttrium Aluminium Garnet (Er:YAG with RecoSMA (Reconstructive Spatially Modulated Ablation module for distributing laser radiation into microbeams) laser technology versus sharp debridement in 144 patients (treatment group N = 71; control N = 73) with diabetic foot, venous and arterial leg ulcers. The median ulcer size at baseline in the treatment and control group was 11 cm2 and 10 cm2 with median ulcer duration of 16 months and 15 months, respectively. The endpoints were the time to achieve a clean wound bed, time to granulation, extent of complete and marginal epithelialisation, change in wound area, presence of bacteria, levels of topical wound pain, and the patients' tolerance of debridement. A difference at p < 0.05 was considered statistically significant. After a 30‐day observation period, complete epithelialisation occurred in more than twice as many wounds in the treatment group (56.3%) compared to the control group (26%). The Er:YAG laser was more effective than sharp debridement in clearing wounds of microbial flora, stimulating tissue regeneration, promoting early granulation, marginal epithelialisation and wound healing, suggesting that Er:YAG laser therapy may offer greater benefits than conventional methods of sharp debridement of slow healing wounds.

The gap junction protein, connexin43 (Cx43), has critical roles in the inflammatory, edematous, and fibrotic processes following dermal injury and during wound healing, and is abnormally upregulated at the epidermal wound margins of venous leg ulcers (VLUs). Targeting Cx43 with ACT1, a peptide mimetic of the carboxyl-terminus of Cx43, accelerates fibroblast migration and proliferation, and wound reepithelialization. In a prospective, multicenter clinical trial conducted in India, adults with chronic VLUs were randomized to treatment with an ACT1 gel formulation plus conventional standard-of-care (SOC) protocols, involving maintaining wound moisture and four-layer compression bandage therapy, or SOC protocols alone. The primary end point was mean percent ulcer reepithelialization from baseline to 12 weeks. A significantly greater reduction in mean percent ulcer area from baseline to 12 weeks was associated with the incorporation of ACT1 therapy (79% (SD 50.4)) as compared with compression bandage therapy alone (36% (SD 179.8); P=0.02). Evaluation of secondary efficacy end points indicated a reduced median time to 50 and 100% ulcer reepithelialization for ACT1-treated ulcers. Incorporation of ACT1 in SOC protocols may represent a well-tolerated, highly effective therapeutic strategy that expedites chronic venous ulcer healing by treating the underlying ulcer pathophysiology through Cx43-mediated pathways.