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Varicose Ulcer clinical trials

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NCT ID: NCT05707169 Active, not recruiting - Venous Leg Ulcer Clinical Trials

Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Varicose Vein

Start date: January 4, 2023
Phase: N/A
Study type: Interventional

EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT). In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV.

NCT ID: NCT05007301 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Geko™ Cross Therapy Registry - Wound

CTR-Wound
Start date: April 4, 2022
Phase:
Study type: Observational [Patient Registry]

The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.

NCT ID: NCT04927702 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Start date: July 19, 2021
Phase: N/A
Study type: Interventional

In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)

NCT ID: NCT04828304 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

PLASOMA Ultimate Safety & Efficacy Study

PULSE
Start date: May 26, 2021
Phase: N/A
Study type: Interventional

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: 1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; 2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: - FU1: 2 weeks after end treatment period - FU2: 12 weeks after end treatment period - FU3: 12 months after start treatment.

NCT ID: NCT04823962 Active, not recruiting - Venous Leg Ulcer Clinical Trials

Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

Start date: March 11, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.

NCT ID: NCT04181320 Active, not recruiting - Venous Leg Ulcer Clinical Trials

A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).

Granulox01
Start date: June 8, 2020
Phase: N/A
Study type: Interventional

The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure. The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.

NCT ID: NCT03744858 Active, not recruiting - Inflammation Clinical Trials

The Role of Pyroptosis in Chronic Venous Disease

PYROCVD
Start date: November 12, 2018
Phase:
Study type: Observational

Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.

NCT ID: NCT03736941 Active, not recruiting - Venous Leg Ulcer Clinical Trials

Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice

INVICTUS
Start date: April 16, 2019
Phase: N/A
Study type: Interventional

The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression. In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '. The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.

NCT ID: NCT03200353 Active, not recruiting - Ulcer Venous Clinical Trials

Evaluation of Sores Treatment by Oxygenotherapy

Start date: April 10, 2017
Phase: N/A
Study type: Interventional

Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day. The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.

NCT ID: NCT03154619 Active, not recruiting - Venous Leg Ulcer Clinical Trials

Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.