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Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84–126) in the hosiery group and 98 days (85–112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. Two-layer compression hosiery is a viable alternative to the four-layer bandage—it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. NIHR Health Technology Assessment programme (07/60/26).

Deep vein thrombosis (DVT) and pulmonary embolism are common after stroke. In small trials of patients undergoing surgery, graduated compression stockings (GCS) reduce the risk of DVT. National stroke guidelines extrapolating from these trials recommend their use in patients with stroke despite insufficient evidence. We assessed the effectiveness of thigh-length GCS to reduce DVT after stroke. In this outcome-blinded, randomised controlled trial, 2518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centres in the UK, Italy, and Australia. Patients were allocated via a central randomisation system to routine care plus thigh-length GCS (n=1256) or to routine care plus avoidance of GCS (n=1262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7–10 days and, when practical, again at 25–30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention to treat. This study is registered, number ISRCTN28163533. All patients were included in the analyses. The primary outcome occurred in 126 (10·0%) patients allocated to thigh-length GCS and in 133 (10·5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0·5% (95% CI −1·9% to 2·9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4·18, 95% CI 2·40–7·27). These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results. Medical Research Council (UK), Chief Scientist Office of Scottish Government, Chest Heart and Stroke Scotland, Tyco Healthcare (Covidien) USA, and UK Stroke Research Network.

Reduced venous return is an important trigger of vasovagal syncope (VVS). Elastic compression stockings (ECS) can modify venous return and be of therapeutic interest; however, evidence for ECS efficacy in VVS is scarce. This randomized controlled trial was designed to address the issue. COMFORTS-II is a multicenter, triple-blind, parallel design, randomized controlled trial aimed to assess the efficacy of ECS in preventing VVS recurrences. Using central online randomization, 268 participants will be allocated to 2 arms (1:1 ratio), wearing intervention ECS (25-30 mm Hg pressure) or sham ECS (≤10 mm Hg pressure). All participants will receive standard VVS treatment in the form of education, and lifestyle modification recommendations (drinking 2-3 l/d of fluids and consuming 10 g/d—roughly half a tablespoon—of table salt). Adherence to ECS treatment will be evaluated through diary sheets, and compared between study arms. Follow-up continues for 1 year, and is conducted via a 24/7 phone line available to patients and trimonthly visits. The co-primary outcomes are proportion of participants with any syncopal recurrence and time to first syncopal episode. Secondary outcomes include frequency of VVS spells, time intervals between recurrences, and incidence of any patient-reported adverse effects. To the best of our knowledge, COMFORTS-II is the first clinical trial to assess ECS efficacy among patients with VVS, addressing an important gap in evidence for VVS treatments.

IntroductionHospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.Methods and analysisA multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18–59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.Ethics and disseminationEthical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberISRCTN13908683.

Background Leg cramps are common among older adults and often lead to sleep disturbances and reduced quality of life. However, there is no consensus on how to treat this condition. This study aimed to evaluate the effectiveness of compression stockings in preventing leg cramps in individuals aged 50 to 85. Methods This study was a three-arm, parallel-group, partially blinded, randomized placebo-controlled trial conducted in Finland. Participants were recruited nationwide through online advertisements and primary care centers. Eligible individuals had experienced at least two leg cramps per week during the previous 4 weeks. Participants were randomized to receive either knee-high medical compression stockings, magnesium hydrochloride, or placebo pills, to be used daily for 4 weeks. The primary outcome was the change in leg cramp frequency at week 8. Secondary outcomes included the number of leg cramp-related nocturnal awakenings and the perceived pain intensity on an ordinal scale. Results A total of 121 participants were randomized, and 109 (90.1%) completed the trial. The primary outcome analysis included 114 participants. The mean age was 65.8 years ( SD 7.8), and 87 (71.9%) were women. At baseline, the median number of weekly leg cramps was 4 ( IQR 3–7). At week 8, the median weekly leg cramp frequency was 2 ( IQR 1–2.5) in the compression stockings group, 3 ( IQR 2–6) in the magnesium group, and 3 (IQR 2–5) in the placebo group. The baseline-adjusted mean difference in leg cramp frequency between the compression stockings and placebo group was −1.43 (95% CI −2.36 to −0.50; P  = .001). No significant difference was observed between the magnesium and placebo groups, with an adjusted mean difference of −0.20 (95% CI −1.49 to 1.09; P  = 0.929). Four participants discontinued compression stockings due to adverse reactions. No serious adverse events were reported. Conclusions Among older adults, daily use of compression stockings was effective in reducing the frequency and pain intensity of leg cramps, as well as the number of nocturnal awakenings caused by them. Trial registration ClinicalTrials.gov NCT04694417. Registered on 4 January 2021.

Functional proprioceptive information is required to allow an individual to interact with the environment effectively for everyday activities such as locomotion and object manipulation. Specifically, research suggests that application of compression garments could improve proprioceptive regulation of action by enhancing sensorimotor system noise in individuals of different ages and capacities. However, limited research has been conducted with samples of elderly people thus far. This study aimed to examine acute effects of wearing knee-length socks (KLS) of various compression levels on ankle joint position sense in community-dwelling, older adults. A total of 26 participants (12 male and 14 female), aged between 65 and 84 years, were randomly recruited from local senior activity centres in Singapore. A repeated-measures design was used to determine effects on joint position awareness of three different treatments–wearing clinical compression socks (20–30 mmHg); wearing non-clinical compression socks (< 20 mmHg); wearing normal socks, and one control condition (barefoot). Participants were required to use the dominant foot to indicate 8 levels of steepness (2.5°, 5°, 7.5°, 10°, 12.5°, 15°, 17.5°, and 20°), while standing on a modified slope box, in a plantar flexion position. Findings showed that wearing clinical compression KLS significantly reduced the mean absolute errors compared to the barefoot condition. However, there were no significant differences observed between other KLS and barefoot conditions. Among the KLS of various compression levels, results suggested that only wearing clinical compression KLS (20–30 mmHg) improved the precision of estimation of ankle joint plantar flexion movement, by reducing absolute performance errors in elderly people. It is concluded that wearing clinical compression KLS could potentially provide an affordable strategy to ameliorate negative effects of ageing on the proprioception system to enhance balance and postural control in community-dwelling individuals.

PurposeWe examined the possibility that wearing a below-knee compression garment (CG) reduces fatigue-induced strength loss and joint position sense (JPS) errors in healthy adults.MethodsSubjects (n = 24, age = 25.5 ± 4 years) were allocated to either one of the treatment groups that performed 100 maximal isokinetic eccentric contractions at 30°−1 with the right-dominant knee extensors: (1) with (EXPCG) or (2) without CG (EXP) or to (3) a control group (CONCG: CG, no exercise). Changes in JPS errors, and maximal voluntary isometric contraction (MVIC) torque were measured immediately post-, 24 h post-, and 1 week post-intervention in each leg. All testing was done without the CG.ResultsCG afforded no protection against JPS errors. Mixed analysis of variance (ANOVA) revealed that absolute JPS errors increased post-intervention in EXPCG and EXP not only in the right-exercised (52%, p = 0.013; 57%, p = 0.007, respectively) but also in the left non-exercised (55%, p = 0.001; 58%, p = 0.040, respectively) leg. Subjects tended to underestimate the target position more in the flexed vs. extended knee positions (75–61°: − 4.6 ± 3.6°, 60–50°: − 4.2 ± 4.3°, 50–25°: − 2.9 ± 4.2°), irrespective of group and time. Moreover, MVIC decreased in EXP but not in EXPCG and CONCG at immediately post-intervention (p = 0.026, d = 0.52) and 24 h post-intervention (p = 0.013, d = 0.45) compared to baseline.ConclusionAltogether, a below-knee CG reduced fatigue-induced strength loss at 80° knee joint position but not JPS errors in healthy younger adults.

Background The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression. Methods/Design The trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm 2 or >10 cm 2 . Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process. Discussion The aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes. Trial Registration ACTRN12608000599370

Background For patients with varicose veins, the goal is to relieve pain and swelling, reduce the severity of edema, improve skin changes, and heal ulcers associated with venous disease. Compression therapy is the cornerstone of their management. Several studies have shown that wearing an elastic bandage for the first 24 h and then a compression stocking for a week can effectively reduce the pain after thermal ablation. However, in clinical practice, patient compliance with this treatment could be better, considering difficulties in pulling up and removing the compression stocking, tightness, and skin irritation because these must be worn for a prolonged period. A potential solution to battling these barriers is short-term compression therapy. Besides, the effect and necessity of wearing compression stockings after thermal ablation have been questioned. Based on current clinical experience and limited evidence, although some scholars have suggested that compression therapy may be an unnecessary adjunctive therapy after thermal ablation, there is still a great deal of uncertainty in the absence of compression therapy after thermal ablation compared to compression therapy. Therefore, we advocate further research to evaluate the clinical effect of short-term postoperative compression therapy. Furthermore, well-designed randomized controlled trials are needed. Methods A prospective, multicenter, non-inferiority randomized controlled trial is designed to evaluate the non-inferiority of target vein occlusion rate at 3 months. Three hundred and sixty patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) 3 M™ Coban™ elastic bandage for 48 h or (B) 3 M™ Coban™ elastic bandage for the first 24 h and then a class II compression full-length stocking (23–32 mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator), pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to regular work, and compliance. Discussion Suppose the effect of the 3 M™ Coban™ elastic bandage for 48 h proves to be non-inferior to long-term compression therapy. In that case, this short-term treatment may contribute to a future update of clinical guidelines for compression therapy after thermal ablation of varicose veins, resulting in higher patient compliance and better postoperative quality of life. Trial registration Clinical Trials NCT05840991 . Registered on May 2023.

Background and Objective: Although compression therapy is a very effective therapy in reducing stasis-induced complaints, the wearing comfort is not always as requested. Most frequent problems are dryness of the skin and itching. This randomized, cross-over trial investigated 33 healthy participants and compared 2 different medical compression stockings: conventional stockings (type A = MCS) versus compression stockings with integrated care emulsion (type B = MCS-SkC). Methods: Participants were divided into 2 cohorts. Both compression types were worn one after the other, 1 week each. The cohorts were named according to the sequence of the wearing periods (cohort AB/BA). Primary outcome: skin hydration. Secondary outcomes: transepidermal water loss (TEWL), skin roughness, leg volume, interface pressure, and questionnaires about stasis-induced complaints and wearing comfort. Results: Skin hydration: significant reduction after wearing MCS in both cohorts (p < 0.001); preservation of skin moisture after wearing MCS-SkC (p = 0.546 and p = 0.1631). TEWL: significant increase after wearing MCS (p = 0.007 and p = 0.0031); significant reduction by wearing MCS-SkC (p = 0.006 and p = 0.0005). Skin roughness: significant increase after wearing MCS (p = 0.0015 and p = 0.010), and nonsignificant decrease of skin roughness after wearing MCS-SkC (p = 0.933 and p = 0.4570). Leg volume: significantly reduced with both stockings (p = 0.004 and p = 0.0047). Regarding stasis-induced complaints, both stockings achieved good results. Conclusions: Both compression stockings are appropriate to reduce leg edema and minimize leg symptoms. MCS-SkC helps to obtain the natural skin barrier function in preserving the epidermal water content and reducing the TEWL.