Graduated Compression Elastic Stockings Reduce Lipodermatosclerosis and Ulcer Recurrence

2000 ◽  
Vol 15 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Y. K. Vandongen ◽  
M. C. Stacey
Keyword(s):  
Controlled Trial ◽  
Venous Ulcer ◽  
Control Group ◽  
Venous Disease ◽  
Ulcer Recurrence ◽  
Compression Stockings ◽  
Venous Ulceration ◽  
Tertiary Teaching ◽  
Elastic Stockings ◽  
Randomised Controlled

Objective: To assess the effect of elastic stockings on reducing the area of lipodermatosclerosis in patients with healed venous ulceration. Design: Patients in this study were part of a randomised controlled trial to assess elastic stockings in preventing venous ulcer recurrence. Setting: Leg ulcer clinic at a tertiary teaching hospital. Patients: Consecutive consenting patients with leg ulcers due to venous disease alone, that had healed 2 weeks previously. Interventions: Patients were randomised to below-knee graduated compression stockings (Venosan 2003) or no stockings. Main outcome measures: Patients had the area of lipodermatosclerosis measured on admission to the study and at 6-monthly intervals. Time to ulcer recurrence was also recorded for a 2-year follow-up period. Results: One hundred and fifty-three patients were randomised to the main study (stockings 72, no stockings 81); 52 had re-ulcerated by 6 months (15 stockings, 37 no stockings). Lipodermatosclerosis was significantly reduced after 6 and 12 months in those patients wearing stockings but not in the control group (repeat measures ANOVA p = 0.01, p = 0.04). The initial area of lipodermatosclerosis was significantly larger in those patients who re-ulcerated within 2 years of entering the study compared with those who did not re-ulcerate (re-ulceration, 293 cm2; no re-ulceration, 50 cm2). Conclusions: Elastic stockings alone can improve the skin changes of lipodermatosclerosis and lower the rate of ulcer recurrence.

Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial

2018 ◽  
Vol 34 (4) ◽  
pp. 224-230 ◽  
Author(s):  
Linda P Arendsen ◽  
Stella Vig ◽  
Ranee Thakar ◽  
Abdul H Sultan
Keyword(s):  
Surface Area ◽  
Controlled Trial ◽  
Chronic Venous Disease ◽  
Control Group ◽  
Venous Disease ◽  
Compression Stocking ◽  
Compression Stockings ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

Objective Compression stockings are the primary treatment for lipodermatosclerosis secondary to chronic venous disease, but do not improve the skin condition. The aim of this study was to investigate the impact of copper on lipodermatosclerosis. Methods A double-blind randomised controlled pilot study was performed including patients with bilateral lipodermatosclerosis. One compression stocking of a pair was impregnated with copper. Symptom score and surface area of lipodermatosclerosis were assessed at baseline, after 2, 4 and 8 weeks. Results Sixteen patients were included. There was no significant difference in mean symptom scores; however, there was a significant reduction of the surface area in the study group 42,637 to 35,739 mm2 versus 41,487 to 43,210 mm2 in the control group (p = 0.04). Conclusion This study demonstrates the beneficial effect of copper on lipodermatosclerosis secondary to chronic venous disease with reduction in surface area but no benefit on symptoms. Trials identification number: NCT03283800

Influence of perforating vein surgery in patients with venous ulceration

2013 ◽  
Vol 30 (2) ◽  
pp. 127-132 ◽  
Author(s):  
WB van Gent ◽  
CHA Wittens
Keyword(s):  
Ulcer Healing ◽  
Controlled Trial ◽  
Clinical Importance ◽  
Compression Therapy ◽  
Venous Ulcer ◽  
Ulcer Recurrence ◽  
Recurrence Rates ◽  
Venous Ulceration ◽  
Perforating Veins ◽  
Perforating Vein

Objectives The exact role of perforating vein surgery is still unclear. The aim of this study is to analyze the influence of perforating vein surgery in patients with venous ulceration. Methods This study was part of a randomized controlled trial in which conservative and surgical treatment of venous ulceration was compared. It is a secondary analysis of prospectively gathered data. Ninety-seven active leg ulcers were surgically treated with a subfascial endoscopic perforating vein surgery (SEPS) procedure. Concomitant superficial venous incompetence was treated with flush saphenopopliteal ligation and/or saphenofemoral ligation and limited stripping of the great saphenous vein. All patients were also treated with ambulatory compression therapy. Ulcer healing and recurrences are described in detail. To measure the completeness of the SEPS procedure duplex ultrasonography was performed on each patient before and 6 weeks and 12 months after surgery. Also newly formed perforators after surgery were scored and their influence was analyzed. Results Analyses were performed on 94 ulcerated legs with a mean follow-up of 29 months. In all treated legs, only 45% all perforators were treated. In 55% one (29%) or more (26%) perforators were missed. Healing was not significantly influenced by the number of remaining incompetent perforating veins, but recurrence was significantly higher in patients who had incomplete SEPS procedure ( p = 0.007 log-rank). New incompetent perforating veins did not affect ulcer healing or recurrence. The plotted location of new perforators did not show a pattern. Deep vein incompetence and treatment of superficial venous incompetence had no significant influence on healing or recurrence rates in a complete or incomplete SEPS procedure. Conclusion In this series a well-performed SEPS procedure lowers the venous ulcer recurrence rate significantly, indicating the clinical importance of incompetent perforating veins in patients with an active venous ulcer.

Systematic Reviews of Prevention of Venous Ulcer Recurrence

2001 ◽  
Vol 16 (1) ◽  
pp. 20-23 ◽  
Author(s):  
E. A. Nelson
Keyword(s):  
Systematic Reviews ◽  
Data Extraction ◽  
Venous Ulcer ◽  
Ulcer Recurrence ◽  
Recurrence Rates ◽  
Venous Ulceration ◽  
Treatment Regimens ◽  
Venous Ulcers ◽  
Weak Evidence ◽  
Randomised Controlled

Aim: To illustrate and discuss the role of systematic reviews in assessing the effect of interventions used in preventing recurrence of venous ulceration. Method: Systematic review of randomised controlled trials (RCTs) reporting the recurrence of venous ulcers. We searched the Cochrane Wounds Group specialised trial register in June 2000. This contains results of searches for RCTs in 18 electronic databases and hand searches. Trials were assessed for inclusion by two people and data extraction was performed using a standard proforma. Synthesis: We found weak evidence that wearing compression hosiery reduces recurrence rates. There was insufficient evidence for the effectiveness of drugs, vein surgery, exercise or leg elevation. Conclusions: Where systematic reviews provide clear implications for practice are found, clinicians can incorporate these into treatment regimens. Where results indicate that there is clinical uncertainty, as in the prevention of recurrence, this can assist commissioners and researchers in prioritising research questions.

Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

2018 ◽  
Vol 3 (07) ◽  
Author(s):  
Ms. Sonam Yangchen Bhutia ◽  
Dr. Sushma Kumari Saini ◽  
Dr. Manmeet Kaur ◽  
Dr. Sandhya Ghai
Keyword(s):  
School Children ◽  
Home Visit ◽  
Controlled Trial ◽  
Family Members ◽  
Sampling Technique ◽  
Control Group ◽  
Food Hygiene ◽  
Parent Communication ◽  
Post Test ◽  
Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members.  After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kristina Traxler ◽  
Franz Schinabeck ◽  
Eva Baum ◽  
Edith Klotz ◽  
Barbara Seebacher
Keyword(s):  
Randomised Controlled Trial ◽  
Ankle Joint ◽  
Manual Therapy ◽  
Controlled Trial ◽  
Daily Activities ◽  
Control Group ◽  
Chronic Stage ◽  
Post Stroke ◽  
Randomised Controlled ◽  
Task Oriented

Abstract Background Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. Methods This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Discussion Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. Trial registration German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

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