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Leg Ulcer clinical trials

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NCT ID: NCT04613687 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

FREEDOM
Start date: October 30, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

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: NCT03618615 Not yet recruiting - Arteritic Leg Ulcer Clinical Trials

Anatomical Study of the Arteries of the Skin on Amputation Legs

APIA
Start date: September 30, 2018
Phase:
Study type: Observational

PRIMARY OBJECTIVE Qualitatively describe the distribution of cutaneous arteries in patients with long-term occlusive arterial disease. SECONDARY OBJECTIVE To compare the distribution of cutaneous arteries observed on the legs of arteritic patients with that observed on non-arteritic legs (from bodies given to science).

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: NCT02993809 Not yet recruiting - Diabetic Foot Clinical Trials

Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia

Start date: March 2018
Phase: Phase 1
Study type: Interventional

The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.

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: 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.