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Venous Leg Ulcer clinical trials

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NCT ID: NCT04461132 Completed - Venous Leg Ulcer Clinical Trials

The Effect of Manual Lymphatic Drainage

Start date: September 11, 2018
Phase: N/A
Study type: Interventional

In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.

NCT ID: NCT04249661 Completed - Venous Leg Ulcer Clinical Trials

Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates

Start date: January 9, 2020
Phase:
Study type: Observational

This Study aims to identify whether venous leg ulcers which are colonised by Pseudomonas Aeruginosa cause more pain than those which are not and if this bacteria affects healing time. This may determine how venous ulcer infections are treated in order to improve symtomatology and quality of life for patients with these chronic wounds.

NCT ID: NCT04046120 Completed - Venous Ulcer Clinical Trials

Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers

COMPARACHILLE
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .

NCT ID: NCT04011371 Completed - Venous Leg Ulcer Clinical Trials

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Venous leg ulcers (VLUs) are a common wound with significant morbidity and cost, and suboptimal therapeutic options. VLUs result from chronic venous insufficiency, including venous reflux and post-thrombotic syndrome. VLU can take from months to years to heal, and 54-78% recur. Current therapies include wound, compression therapy, and medications. These treatments can increase the rate of healing, and reduce recurrence, however these therapies can be burdensome, painful, and ineffective, and despite these therapies, ~50% of wounds become chronic. Chronic VLUs can be painful, malodorous, and infected, and they often significantly limit an individual's function and mobility. An emerging therapy for symptomatic venous reflux is the closure of the culprit vein by endovenous closure with a cyanoacrylate adhesive implant. Recent studies show cyanoacrylate closure (CAC) to be a safe and effective treatment for varicosities resulting from symptomatic incompetent great saphenous veins. This study will evaluate the safety and effectiveness of CAC for VLUs.

NCT ID: NCT03903692 Completed - Venous Leg Ulcer Clinical Trials

A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers

Start date: September 30, 2019
Phase: N/A
Study type: Interventional

Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.

NCT ID: NCT03881267 Completed - Venous Leg Ulcer Clinical Trials

SkinTE® in the Treatment of Venous Leg Wounds

Start date: March 29, 2019
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds

NCT ID: NCT03818828 Completed - Venous Leg Ulcer Clinical Trials

Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)

Start date: February 14, 2019
Phase: Phase 2
Study type: Interventional

It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.

NCT ID: NCT03795064 Completed - Venous Ulcer Clinical Trials

Immediate Versus Early Endovenous Ablation In Venous Ulcer

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

NCT ID: NCT03699072 Completed - Venous Leg Ulcer Clinical Trials

DermaRep™ Device in the Treatment of Venous Leg Ulcers

DermaRep™
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.

NCT ID: NCT03662997 Completed - Diabetic Foot Ulcer Clinical Trials

Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Start date: March 19, 2019
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.