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Varicose Ulcer clinical trials

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NCT ID: NCT04370106 Not yet recruiting - Venous Leg Ulcer Clinical Trials

The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes

legclub
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP). Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence). Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU.

NCT ID: NCT03670329 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Management of Infection Risk in Non-comparative Trial (MINT)

MINT
Start date: October 2018
Phase: N/A
Study type: Interventional

The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection. The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

NCT ID: NCT03543007 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Approximately 200 patients (100 in each treatment group) nationally with chronic venous leg ulcers will be randomized to GrafixPLâ„¢PRIME plus standard compression therapy or standard compression therapy alone for up to 12 weeks in order to compare the clinical outcomes between the two groups. Specifically, at this Georgetown site, approximately 30 subjects will be recruited.

NCT ID: NCT02873728 Not yet recruiting - Leg Ulcer Clinical Trials

Remote Ischemic Conditioning for Treatment of Chronic Wounds

Start date: November 2016
Phase: N/A
Study type: Interventional

The goals of this series of studies is to test the effect of RIC on chronic leg ulcers (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled study.

NCT ID: NCT02845466 Not yet recruiting - Clinical trials for Foot Ulcer, Diabetic

Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Start date: August 2018
Phase: Phase 3
Study type: Interventional

Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.

NCT ID: NCT02798445 Not yet recruiting - Venous Ulcer Clinical Trials

TAPIRS Technique Plus Adjustable Compression System in Treatment of Venous Leg Ulcers

TAPIRS
Start date: June 2016
Phase: N/A
Study type: Interventional

The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.

NCT ID: NCT01770509 Not yet recruiting - Leg Ulcer Clinical Trials

The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

Start date: February 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Ulcers of the lower extremities, particularly in patients older than 65 years, are common among the population. Studies estimate the prevalence of current chronic leg ulcers at approximately 1%. The most common cause (approximately 80%) is thought to be chronic venous insufficiency disease. Recurrent cellulitis is an additional common cause. The ulcers cause a significant morbidity and negative impact on the patients' quality of life. The care of chronic vascular ulcers places a significant burden on the patient and the health care system. Additionally, these nonhealing ulcers place the patient at much higher risk for lower extremity amputation. Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

NCT ID: NCT01491438 Not yet recruiting - Venous Ulcers Clinical Trials

Plasma Rich Growth Factors in Venous Ulcers

Start date: November 2013
Phase: N/A
Study type: Interventional

OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment. SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment. Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit. STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.

NCT ID: NCT00815217 Not yet recruiting - Diabetic Wounds Clinical Trials

The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers

Start date: February 2009
Phase: N/A
Study type: Interventional

A prospective, single blinded randomized clinical study will be performed to determine if the injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or wound closure at a faster rate than conventional treatment.