Ulcus cruris venosum: Was bringt die frühzeitige endovenöse Ablation bei venösen Ulzerationen?

<b>Importance:</b> One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. <b>Objective:</b> To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. <b>Design, Setting, and Participants:</b> Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. <b>Interventions:</b> Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. <b>Main Outcomes and Measures:</b> The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. <b>Results:</b> The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57–1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480–0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12–1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. <b>Conclusions and Relevance:</b> Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. <b>Trial Registration:</b> ClinicalTrials.gov identifier: ISRCTN02335796.

Incidence of Recurrent Venous Ulcer in Patients Treated at an Outpatient Clinic: Historical Cohort

The recurrence of venous ulcers is the wound reopening after a period of completed epithelisation of a previous ulcer due to exposure to causal factors and lack of prevention. Venous ulcers have a high recurrence rate that may increase through the years. Epidemiological evidence on its incidence and risk factors is scarce due to the lack of patient follow-up in outpatient clinics and adherence to treatment after healing. The objective was to analyze the incidence of venous ulcers recurrency in outpatients and the risk factors for its occurrence. It is an observational historical cohort with retrospective data collection, performed through electronic medical records. Setting: private health insurance outpatient clinic. The participants were adult patients with healed venous ulcers. Incidence of venous ulcer recurrence was calculated within individuals with healed ulcers from 2014 and 2018 with a follow-up of at least one year. Bivariate analysis and logistic regression were used to explore risk factors considering demographic, clinical, and wound-related variables. As a result, sixty-five (65) of the 134 patients with healed venous ulcers had a recurrence, leading to an incidence of 48.5%, with a mean onset time of 230.1 (SD 267) days. Patients with recurrent venous ulcers were primarily women (39/48.1%), with a mean age of 64 (SD 15.5) years, 57 (50.8%) had some comorbidity, with systemic arterial hypertension as the most frequent (47/51%). Obesity (15/88.2%) increased the risk of venous ulcers recurrence by 8.7 (OR 95% CI 2.1-60.8; P = .009) times. In conclusion, venous ulcers recurrence incidence was 48.5%, with obesity as a risk factor. This study demonstrates that the clinical approach of people with venous ulcers should not finish when the wound is healed. For ulcer recurrence prevention interventions addressing systemic factors, besides topical management of the wound, are essential.

Decreased mobility, lack of social support, haemosiderosis and use of antidepressant medications may predict recurrent venous leg ulcers within 12 months of healing: A prospective longitudinal study

Aim To identify clinical, medical and psychosocial predictors of venous leg ulcer recurrence within 12 months of healing. Methods A multi-site study was conducted in Australia in community and hospital outpatient settings. Adults with venous leg ulcers were recruited within 4 weeks of healing and data were collected on preventative treatments and health, medical, clinical and psychosocial factors. Follow-up data on recurrences were collected every 3 months until ulcer recurrence, or until 12 months after healing pending which occurred first. Factors associated with time to recurrence were analysed using a Cox proportional hazards regression model. Design Secondary data analysis of a multi-site, prospective longitudinal study to validate a risk assessment tool for recurrence. Results A sample of 143 participants was recruited (51% male, M age = 73 years, SD 13.6). Almost half (49.6%) had an ulcer recurrence within 12 months, with a mean time to ulcer recurrence of 37 weeks ( SE 1.63, 95% CI 33.7–40.1). Factors measured at the time of healing that were significant independent predictors of recurrence were: prescribed antidepressant medications ( p = .035), presence of haemosiderosis ( p = .006), decreased mobility (longer sitting times) ( p = .007) and lower social support scale scores ( p = .002). Participants who wore compression systems providing 20 mmHg or higher for at least 5 days/week were less likely to recur, although not reaching statistical significance ( p = .06). Conclusion Results provide evidence that antidepressant medications, haemosiderosis, decreased mobility and lack of social support are risk factors associated with ulcer recurrence; therefore, these variables are modifiable and could guide early intervention.

Molecular and epidemiological characterization of recurrent Mycobacterium ulcerans infections in Benin

Background Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans, an environmental mycobacterium. Although transmission of M. ulcerans remains poorly understood, the main identified risk factor for acquiring Buruli ulcer is living in proximity of potentially contaminated water sources. Knowledge about the clinical features of Buruli ulcer and its physiopathology is increasing, but little is known about recurrence due to reinfection. Methodology/Principal findings We describe two patients with Buruli ulcer recurrence due to reinfection with M. ulcerans, as demonstrated by comparisons of DNA from the strains isolated at the time of the first diagnosis and at recurrence. Based on the spatial distribution of M. ulcerans genotypes in this region and a detailed study of the behavior of these two patients with respect to sources of water as well as water bodies and streams, we formulated hypotheses concerning the sites at which they may have been contaminated. Conclusions/Significance Second episodes of Buruli ulcer may occur through reinfection, relapse or a paradoxical reaction. We formally demonstrated that the recurrence in these two patients was due to reinfection. Based on the sites at which the patients reported engaging in activities relating to water, we were able to identify possible sites of contamination. Our findings indicate that the non-random distribution of M. ulcerans genotypes in this region may provide useful information about activities at risk.

Impact of educational nursing intervention on compression therapy adherence and recurrence of venous leg ulcers: a quasi-experimental study

Following the healing of venous leg ulcers, the primary problems for nursing and patients are adhering to compression therapy and preventing ulcer recurrence. As a result, it is important that patients comprehend their situation. The purpose of this study is to see how an educational nursing intervention affected compression therapy adherence and recurrence of venous leg ulcers in patients with chronic venous leg ulcers. A quasi-experimental design is used, including an intervention, a control group, and before and post-assessments. This study is conducted in one of Egypt's largest teaching hospitals associated with Menoufia University. A 20-month study included 80 adult patients with healed venous leg ulcers. Each participant is randomized to either a control (got regular leg ulcer information) or study (received educational interventions) group. The following tools are used in the study: bio-sociodemographic variables, knowledge evaluation, compression therapy adherence scale, and recurrence follow-up, after three, six, and twelve months of implementation. Furthermore, there is a statistically significant difference between the study groups during the pretest (r=0.885, 0.774, 0.477, p=0.002). The use of nurse education increased patients' understanding and adherence to compression treatment substantially. As a consequence, those with chronic venous leg ulcers may be able to avoid recurrent venous leg ulcers.

Mesenchymal stromal cells therapy alone does not lead to the complete restoration of the skin parameters in diabetic foot patients within a 3-year follow-up period

Introduction: Mesenchymal stromal cells (MSCs) administration is an effective option for the treatment of diabetic foot ulcers (DFUs). However, to date, studies assessing long-term outcomes and evaluating skin parameters after cell-based therapy are lacking. We presented the clinical outcomes of 3 patients, treated for DFUs with the bone marrow MSCs 3 years earlier. Methods: Ultrasound examination was used to compare collagen density and epidermal thickness in areas of healed ulcers in comparison with non-affected skin used as a control. Ultrasound and dermatoscopy were used to exclude neoplasm formation, to assess scar contracture and wound recurrence. Results: In all patients, no ulcer recurrence was detected, which was lower than the expected 60% rate of re-ulceration in diabetic patients in a 3-year period (OD [odds ratio] = 0.095, P = 0.12). No neoplasm formation, no contracture of hypertrophic scar, and adjacent tissue were registered. Collagen ultrasound density was decreased by 57% (P = 0.053) and epidermal thickness was increased by 72% (P = 0.01) in the area of healed ulcers in all patients. Conclusion: MSCs therapy alone did not result in the complete restoration of the skin parameters within a 3-year period. MSCs may represent important adjuvant to the therapy, however, other novel approaches are required to achieve better results.

Predictive Factors for Limb Salvage and Foot Ulcer Recurrence in Patients with Chronic Limb-Threatening Ischemia After Multidisciplinary Team Treatment: A 6-Year Japanese Single-Center Study

Chronic limb-threatening ischemia (CLTI) is associated with a short-term risk of limb loss. Multidisciplinary teams are often involved in CLTI treatment; however, in Asian countries, multidisciplinary teams that include podiatrists specializing in foot wounds and vascular surgeons who can perform distal bypass surgery are lacking. We investigated predictive factors for limb salvage and foot ulcer recurrence in patients with CLTI treated by a Japanese single-center intensive multidisciplinary team over 6 years. We retrospectively investigated 84 patients with CLTI and foot ulcers who had undergone revascularization and wound treatment between October 2013 and December 2019. Following postrevascularization treatment, including undertaking minor amputations, the healing rate was 77.8%, and the average wound healing time was 75 ± 68 days. To achieve adequate blood supply, 17.7% of patients were treated using a combination of endovascular revascularization and bypass surgeries. Thirty-three (44%) patients had wound recurrence and there was wound recurrence within 6 months in 58.9% of these patients. Multivariate logistic regression analysis showed that postrevascularization skin perfusion pressure was significantly associated with wound healing (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.033-1.243, P = .0078). Diabetes mellitus (OR 9.72, 95% CI 1.855-50.937, P = .0071), and heart disease (OR 3.51, 95% CI 1.052-11.693, P = .0411) were significantly associated with wound recurrence ( P < .05). Treatment within a single-center intensive multidisciplinary team resulted in good patient outcomes. Our study indicates that the revascularization endpoint of CLTI treatment should be marked by attainment of adequate blood supply and wound healing. The timing of revascularization and debridement is of utmost importance for the successful treatment of CLTI wounds.

Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP)

IntroductionThe skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes.Research design and methodsIn this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (<4 years, n=295), or Charcot’s neuro-arthropathy (n=9) to usual care (ie, podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6–8 plantar sites per foot each day (enhanced therapy). If ∆T>2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site.ResultsOn the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046).ConclusionsAt-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site.Trial registration numberNTR5403.