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Venous Insufficiency clinical trials

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NCT ID: NCT06238791 Completed - Clinical trials for Chronic Venous Insufficiency

Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

Start date: October 5, 2023
Phase:
Study type: Observational

Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.

NCT ID: NCT05610241 Completed - Venous Leg Ulcer Clinical Trials

Preliminary Investigation of a Smart Compression Therapy Prototype

PRESUF-VLU
Start date: March 4, 2023
Phase: N/A
Study type: Interventional

Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.

NCT ID: NCT05520008 Completed - Clinical trials for Venous Insufficiency of Leg

Game-Based Foot & Ankle Exercise for Those With Lower Extremity Edema

Start date: November 3, 2022
Phase: N/A
Study type: Interventional

The present study aims to use a game-based tele-exercise program for patients using a compression garment to improve lower extremity edema. This tele-exercise gaming platform can work as an efficient exercise to improve patients' muscle strength. It also can be helpful in improving edema and venous return and can be used in addition to compression garments to increase efficacy. The sample size (n=30) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the Baylor college of Medicine Clinic based on the inclusion/exclusion criteria. Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. Both groups will receive a compression garment to use for 4 weeks, and in the intervention group, patients will receive a sensor and a tablet to play foot & ankle exercise games twice a day for 5 minutes. Study participation will be 4 weeks for all participants. Participants will be assessed in two visits: a baseline visit (BL) and a visit at the end of the 4 weeks (W4). The primary outcomes will be calf circumference, foot volume, and pitting edema grade. Secondary outcomes include limb strength, foot perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, and quality of life. The coordinator will monitor patients weekly to see their adherence to the compression garment and game-based exercise.

NCT ID: NCT05507346 Completed - Lymphedema Clinical Trials

A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

TEAYS
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

NCT ID: NCT05383469 Completed - Clinical trials for Chronic Venous Insufficiency

Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.

NCT ID: NCT05058989 Completed - Varicose Veins Clinical Trials

The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy

Start date: June 1, 2021
Phase:
Study type: Observational

Varicose veins (VV) are the early sign of Chronic venous insufficiency (CVI) which are characterised by abnormal tortuosity and dilatation of superficial veins of lower limb extremities. Factors for the development of VV exist in literature. However, the exact mechanism remains unclear. The prevalence of VV are greater in women compared to men and also higher in pregnant women compared to non-pregnant women which make pregnant women at higher risk of developing VV. Furthermore, complications of VV have negative impacts on patients' quality of life and health care budget. Therefore, better understanding of the cause of VV can contribute in better quality of life to the patient and provide valuable insights to help in reducing health care cost. The present study will investigate the contribution of both mechanical and chemical factors in pregnant women by taking blood samples for genomic testing, using Duplex ultrasound, vector flow imaging, limb volume assessment using Truncated cone tool, assessment of iliac vein compression using Photoplethysmography (PPG) technique, hormonal blood test and assessing patient's quality of life using Aberdeen Varicose Veins Questionnaire (AVVQ).

NCT ID: NCT04897035 Completed - Lymphedema Clinical Trials

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

TIBER
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

NCT ID: NCT04758728 Completed - Venous Reflux Clinical Trials

Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping

ARESQOLSAVES
Start date: September 10, 2015
Phase: N/A
Study type: Interventional

Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

NCT ID: NCT04757766 Completed - Clinical trials for Chronic Venous Insufficiency

VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)

VAP-PRO-C6
Start date: March 1, 2021
Phase:
Study type: Observational

The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6. This program is planned to be carried out in Russia in 2021-2022.

NCT ID: NCT04558957 Completed - Clinical trials for Chronic Venous Insufficiency, CVI

Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency

POLFLEB
Start date: August 8, 2019
Phase: N/A
Study type: Interventional

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.