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Showing 1-20 of 34 trials
NCT03216005
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
NCT07228585
This study aims to compare the effects of kinesiology taping and interval exercise on reducing symptoms, improving quality of life, and vital parameters in individuals with venous insufficiency. The study will be conducted at the Department of Cardiovascular Surgery, Faculty of Medicine, Necmettin Erbakan University, Konya, and will involve individuals aged 18 to 65 who have been diagnosed with venous insufficiency. Participants will be selected according to inclusion criteria and randomised into three groups. These groups will consist of a group receiving kinesiology taping and lifestyle recommendations, a group receiving kinesiology taping combined with interval exercise and lifestyle recommendations, and a control group receiving only lifestyle recommendations. Participants will be followed up for eight weeks, with assessments conducted twice: before and after treatment. In kinesiology taping groups, taping will be applied twice a week for eight weeks, with a total of sixteen sessions. During application, the lymphatic correction technique will be used to increase venous circulation. Taping will begin over the popliteal vein and be applied along the gastrocnemius, soleus, and tibialis posterior muscles with a tension of fifteen to twenty per cent. Participants will inform the physiotherapist if they experience any discomfort or skin sensitivity related to the bandaging, and skin reactions and tolerance levels will be monitored during weekly check-ups. In the group undergoing interval exercise, participants will participate in a mild to moderate exercise programme for thirty to forty minutes, three days a week for eight weeks. The exercises will be performed under the supervision of a physiotherapist and will be of an intensity equivalent to levels three to five on the Borg scale. The programme will include a five-minute warm-up phase, a twenty-minute main exercise section, and a five-minute cool-down period. The main section will consist of three phases, with low-intensity, moderate-intensity, and recovery exercises applied alternately. In the low-intensity section, light-paced walking and step movements will be performed; in the moderate-intensity section, fast-paced walking, ankle pumping movements, squats or calf raises will be performed; in the recovery section, light walking or wrist movements will be preferred. The main exercise will be completed after the cycle is repeated four times, followed by light stretching movements and diaphragmatic breathing exercises during the cool-down phase. Exercise compliance will be monitored on a weekly basis. Standard lifestyle recommendations will be provided to all groups participating in the study. As lifestyle changes in venous insufficiency have both therapeutic and symptom-reducing effects, participants will be given detailed information on this subject. Lifestyle recommendations include increasing physical activity habits such as walking briskly for at least thirty minutes daily and using stairs. As part of leg elevation recommendations, it will be advised to keep the legs above heart level for fifteen to twenty minutes, two or three times a day. Individuals whose jobs require them to stand still for long periods will be advised to take a short walk every thirty minutes. Nutritional recommendations will emphasise reducing salt intake, drinking at least two litres of water daily, and eating fibre-rich foods. Smoking participants will be counselled to quit and asked to avoid wearing tight trousers and high-heeled shoes. As part of skin care, participants will be instructed to use moisturiser once a day to prevent dryness and cracking in the lower extremities. Lifestyle recommendations will be presented to participants via a brochure, and participants in the control group will also follow the same recommendations. The conditions of the study and safety measures have been determined with great care. All procedures will be performed by experienced physiotherapists, taking into account the participants' medical history and contraindications. Assessments will be conducted twice: at the beginning and at the end of the eight-week period. Measurements will include ankle circumference, pain intensity at rest, during sleep and during exercise, blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation, Borg scale assessment, physical activity level measurement, functional capacity assessment, central sensitisation level and quality of life in venous insufficiency. The six-minute walk test will be used to assess functional capacity, the visual analogue scale will be applied for pain, this parameter will be examined using the central sensitisation inventory, and quality of life will be assessed using scales specific to venous insufficiency. The International Physical Activity Questionnaire will be used for physical activity level.
NCT05504070
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
NCT07449728
Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Similar technical efficacy is expected for laser crossectomy at 1940 nm and 1470 nm. A possible advantage of the 1940 nm wavelength in terms of postoperative pain intensity and the risk of adverse events cannot be ruled out.
NCT06642051
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.
NCT04897035
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
NCT05628688
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
NCT05507346
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
NCT06418282
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
NCT07233616
The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study aims to evaluate the risks and benefits of RFA in this specific, high-risk demographic.This prospective, single-arm, single-center cohort study will enroll 50 patients (initial target sample size) aged ≥80 years with CVI classified as CEAP C3 to C6 and with confirmed great or small saphenous vein reflux. All participants will undergo endovenous RFA under tumescent local anesthesia. The primary outcomes are: 1) the great/small saphenous vein occlusion rate at 6 months, assessed by duplex ultrasonography, and 2) the change in disease-specific quality of life from baseline to 6 months, measured by the Aberdeen Varicose Vein Questionnaire (AVVQ). Secondary outcomes include occlusion rates at 1 and 3 months; complication rates (e.g., deep vein thrombosis, skin burns, paresthesia) within 30 days; and changes in the Venous Clinical Severity Score (VCSS) and the 12-Item Short Form Health Survey (SF-12) at predefined intervals over 6 months.This study is designed to demonstrate a high technical success rate (occlusion rate \>95% at 6 months) and a statistically significant improvement in AVVQ and VCSS scores at 6 months post-procedure. The collected data will provide a detailed profile of complication rates, characterizing the safety of RFA in this very elderly cohort.This study will provide crucial, prospective evidence regarding the efficacy and safety of RFA for treating CVI in octogenarians. The findings are expected to guide clinical decision-making and inform treatment guidelines for this vulnerable and expanding patient population.
NCT05926830
This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.
NCT05982405
The long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. For this reason, in this study, it was aimed to investigate the long-term results of inspiratory muscle training in individuals with chronic venous insufficiency.
NCT06785805
This study aims to retrospectively examine the dataset obtained from a previously conducted study titled 'Inspiratory muscle training in individuals with chronic venous insufficiency: randomized controlled trial'. The previously conducted study was a study investigating the effectiveness of the application, and the current study aims to clarify the gap in the literature with the relationship between the data obtained from the patients at the beginning of that study. This study will be conducted by re-examining the initial data of another study from which data was collected before and conducting new analyses. H0: There is no relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency. H1: There is a relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.
NCT05993650
There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
NCT05383469
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.
NCT03784131
This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in patients with severe chronic venous insufficiency (CVI). For each patient a segment of the femoral vein containing the non-functioning valve will be surgically replaced with a single P-TEV containing a functioning valve.
NCT04558957
The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®. The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.
NCT03904602
The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days
NCT05749471
Chronic Venous Disease (CVD) is a common clinical condition with a high prevalence in the western population that may affect quality of life (QoL) of affected patients for several adverse effects. Sexual dysfunction (SD) also partecipate in the QoL of people and has never specifically studied in CVD patients. The aim of this study is to study SD in CVD patients before and after treatment.
NCT05662761
Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication