BACKGROUND: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual\'s health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU.
OBJECTIVE: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
METHODS: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).
RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.
CONCLUSIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

Despite proven effectiveness, compression therapy is applied in only 20-40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted.

National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported.
The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis.
After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms.
A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.

BACKGROUND: Venous leg ulceration is a chronic, recurring, condition causing significant patient morbidity. Randomised controlled trials evaluating treatments for venous leg ulceration provide evidence for clinical decision-making. For trial findings to be useful, outcomes measured need to be clinically meaningful, and consistently and fully reported across trials. A core outcome set is an agreed and standardised set of outcomes which should be, as a minimum, reported in all trials for a given indication.
OBJECTIVE: To identify the outcome domains and outcomes reported in trials of interventions for venous leg ulceration.
METHODS: A scoping review of the literature was carried out. Randomised controlled trials within Cochrane systematic reviews looking at venous leg ulceration interventions and qualitative studies exploring venous leg ulceration were included.
RESULTS: The review identified 807 outcomes from randomised controlled trials and 15 outcomes from qualitative studies, and these were grouped into 11 outcome domains: healing, patient reported symptoms, clinician reported symptoms, carer reported symptoms, life impacts, clinical signs, clinical measurement, performance of the intervention, resource use (supplies and clinician time) and adverse events. The outcome domain \'healing\' included 111 outcomes, \'symptoms\' 109, \'life impacts\' 30, \'clinical signs\' 88, \'clinical measurement\' 184, \'performance of the intervention\' 58, \'resource use\' 52 and \'adverse events\' 190.
CONCLUSIONS: The scoping review identified a large number of outcomes (n = 822) across 11 related outcome domains, supporting the need for a core outcome set.

Graduated compression, using bandaging or compression stockings, is the gold-standard treatment for the management of venous leg ulcers (VLUs) and preventing recurrence. However, achieving the required pressures on different parts of the leg is extremely difficult, even for experienced practitioners. Inappropriately applied compression can result in delayed healing and poor compliance. Graducheck® is a pressure sensor system that ensures that the prescribed level of compression is being applied accurately. This study aimed to determine if two experienced tissue viability nurses (TVNs) could achieve accurate pressures using four commonly used bandage systems, as measured using Graducheck sensor strips. Ideal pressures were not achieved, but in two systems, once the application pressure was adjusted according to the sensor level, ideal compression was achieved. In the remaining two systems, ideal pressures could not be produced, even after adjustments to application. Clinically, the Graducheck system could improve the standard of compression therapy, as real-time feedback ensures that corrections can be made. However, further work is required to determine why ideal pressures were not achieved in two of the tested systems.

We report a case of venous leg ulceration in a reconstructive oral and maxillofacial surgeon. An online survey was created by the British Association of Oral and Maxillofacial Surgeons (BAOMS) Reconstruction Surgical Subspecialty Interest Group (SSIG), primarily to target head and neck surgeons, to investigate the perceived risk and occurrence of venous leg disease. Two respondents had received treatment for lower limb venous disease thus compromising their ability to work, while 13 had symptoms of early venous disease. Our study shows an interesting area of concern for occupational health in surgeons, particularly in those carrying out long operations, as will be the case for members of the Reconstruction SSIG.

BACKGROUND: A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.
OBJECTIVE: The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.
METHODS: Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Venous leg ulcers (VLU) respond well to compression, yet many ulcers remain unhealed after 1 year. Practitioners could be reluctant to apply compression to patients with significant ulcer pain. This study aimed to capture the views of practitioners on compression therapy for patients with painful VLU. A survey was conducted at a UK meeting in 2019 using handheld voting pads to capture the anonymous responses to four questions to which a mean of 90 practitioners responded. Nearly 40% of practitioners treat six or more patients a day with painful lower-limb ulcers. Some 80% felt confident in managing patients with painful ulcers; yet, most practitioners suggested they would refer onward for pain management. Some 40% would omit or reduce compression therapy as a pain management strategy. This survey supports the need for technological solutions that reduce VLU pain so that patients receive effective compression therapy.

Venous leg ulceration (VLU) is a public health concern that is largely managed in community settings. The present study aimed to survey current VLU management in the community. A 14-question survey was distributed to primary care professionals, and 90 responses were received. Some 54% of respondents stated that they would assess ankle brachial pressure indices (ABPI) for those with VLU, while 25% reported that they would not. Additionally, 62% reported not organising duplex ultrasound scanning. Compression therapy was offered by 82% of respondents. When asked whether VLU patients were referred to specialist services in secondary or tertiary care, some 32% reported that they would. However, 57% reported that, if a study suggested that referral to specialist services was beneficial, they would change their practice. On the basis of the findings, the authors concluded that there is diversity in VLU diagnostic and treatment pathways. New, high-quality evidence may improve practice, but care delivery is influenced by local factors including time and resource distribution.

Venous leg ulceration (VLU) is predominantly managed in primary care by district nurses, however much of the research takes place in secondary care. This study aimed to identify to what extent nurses are involved in publishing VLU research and to ascertain how much VLU research is conducted in primary care. Three searches of literature published between 2015 and 2020 were undertaken, reviewing VLU publications on interventions, quality of life and qualitative research. Some 37% of intervention studies had one or more nurse authors, compared with 65% of quality of life studies and 86% of qualitative research publications. Of papers that providing details of recruitment, 39% of intervention and quality of life studies included primary care as a recruitment setting. Qualitative studies were more likely to recruit from primary as well as secondary care (50%). Nurses are involved in leading VLU research but are more likely to publish quality of life and qualitative research than intervention studies. The majority of nurse authors in this field are based in academic institutions. A minority of studies utilise primary care as a recruitment setting for VLU research. More must be done to enable VLU research in community settings and to promote the involvement of clinical nurses in research.