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Leg Ulcer clinical trials

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NCT ID: NCT02987101 Recruiting - Leg Ulcer Clinical Trials

Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

NCT ID: NCT02842502 Recruiting - Leg Ulcer Clinical Trials

Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers

MecaSkin
Start date: September 2014
Phase: N/A
Study type: Interventional

This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

NCT ID: NCT02609594 Recruiting - Venous Leg Ulcers Clinical Trials

Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers

Start date: November 2015
Phase: N/A
Study type: Interventional

Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain. Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.

NCT ID: NCT02583958 Recruiting - Leg Ulcers Clinical Trials

Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

Start date: October 2014
Phase: N/A
Study type: Interventional

Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.

NCT ID: NCT02352454 Recruiting - Venous Leg Ulcers Clinical Trials

Effectiveness of Aurix Therapy in Venous Leg Ulcers

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

NCT ID: NCT02312518 Recruiting - Venous Leg Ulcers Clinical Trials

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).

NCT ID: NCT02280733 Recruiting - Clinical trials for Peripheral Arterial Disease

A Real World, Observational Registry of Chronic Wounds and Ulcers

USWR
Start date: January 2005
Phase:
Study type: Observational [Patient Registry]

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).

NCT ID: NCT02156102 Recruiting - Genetic Disease Clinical Trials

Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)

Start date: June 16, 2014
Phase:
Study type: Observational

Background: - People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers. These are wounds that develop on the skin and don t go away. Current treatments do not work very well, so researchers want to learn more about why the ulcers happen. They want to find out which bacteria may cause it, and if external factors play a role. Objective: - To study social and environmental factors of sickle cell disease and the causes of sickle cell disease leg ulcers. Eligibility: - People age 18 and older who have sickle cell disease or another red cell disorder, with or without an active leg ulcer. Design: - Participants will have a medical history and clinical evaluation. They will also have blood drawn. - Participants will complete questionnaires about their life, health, environment, stress, and other topics. - Participants may provide a small sample of hair. - Participants will be asked to collect a small amount of saliva. - Participants with leg ulcers will have their skin microbiome sampled. The microbiome is all of the microbes (bacteria and and/or fungi) and their genes in and on the body. Researchers will use swabs to collect skin samples. Photographs will be taken of the skin sample area. - Some participants without leg ulcers also will have their skin microbiome sampled. - Some participants who have their skin microbiome sampled will return for a second visit. At this visit, their microbiome will be resampled. It will take place more than 30 days after the first visit.

NCT ID: NCT01537003 Recruiting - Venus Leg Ulcers Clinical Trials

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test

Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds

NCT ID: NCT01320605 Recruiting - Venous Leg Ulcer Clinical Trials

Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies

Start date: March 2011
Phase: Phase 2
Study type: Interventional

Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.