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Venous Insufficiency of Leg clinical trials

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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: 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: NCT04266496 Completed - Fluid Overload Clinical Trials

Discovering the Effect of Venous Insufficiency on Nocturia

DEVINe
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

With this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia. In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.

NCT ID: NCT04180137 Completed - Clinical trials for Endothelial Dysfunction

Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure

Start date: November 28, 2019
Phase: N/A
Study type: Interventional

Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.

NCT ID: NCT03928197 Completed - Nocturia Clinical Trials

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

DEVINe Pilot
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night. With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).

NCT ID: NCT03429959 Completed - Clinical trials for Venous Insufficiency of Leg

SOCKNLEG Compression Stocking Kit : User Friendliness

SOCKNLEGZH
Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years. After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group. All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.

NCT ID: NCT01603433 Completed - Clinical trials for Venous Insufficiency of Leg

The Sapheon Closure System Feasibility Study

Start date: July 2011
Phase: N/A
Study type: Interventional

This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.

NCT ID: NCT01570101 Completed - Clinical trials for Venous Insufficiency of Leg

European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

eSCOPE
Start date: December 2011
Phase: N/A
Study type: Interventional

The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.