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Leg Ulcer clinical trials

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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NCT ID: NCT02248077 Withdrawn - Clinical trials for Impaired Wound Healing

A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers

Start date: October 2014
Phase: Phase 4
Study type: Interventional

This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).

NCT ID: NCT02224300 Unknown status - Venous Leg Ulcers Clinical Trials

Nursing Care With Patients With Venous Leg Ulcers

Start date: August 2014
Phase: Phase 2
Study type: Interventional

Aims are: - develop an Internet-based education programme about venous leg ulcer nursing care (ELC) - evaluate the clinical, cognitive and economical outcomes of education programme Research questions are: 1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg ulcer nursing care, theoretical knowledge level and practical knowledge)? Hypotheses for research question 1 are: 1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the ELC. 2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing care than those who will not use the ELC. 2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)? Hypotheses for research question 2 are: 1. Ulcer healing progresses better among patients who are taken care by nurses using the ELC. 2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC. 3. Nurses using the ELC will use mire adequate treatment supplies than those who will not use the ELC. 3. What are the economical outcomes (treatment time and supply usage) of ELC? Hypothesis for research question 3 is: 1. The economical expenditures will be lower among nurses using the ELC. The ultimate aim is to promote evidence-based nursing care among patients with venous leg ulcer.

NCT ID: NCT02222467 Completed - Venous Leg Ulcers Clinical Trials

Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers

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

The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with venous leg ulcers.

NCT ID: NCT02167815 Completed - Clinical trials for Venous Leg Ulcer (VLU)

A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

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

This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.

NCT ID: NCT02158806 Completed - Venous Leg Ulcer Clinical Trials

Low Dose Aspirin for Venous Leg Ulcers

Aspirin4VLU
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. There are few effective treatments - compression therapy (tight bandaging or stockings) helps healing, but about half the people with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin as well as using compression may speed up healing for VLU, but the current evidence is not enough to change clinical practice. We will conduct a randomised controlled trial to test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.

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: NCT02154087 Terminated - Venous Leg Ulcers Clinical Trials

A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

MOA 034
Start date: July 2014
Phase: Phase 2
Study type: Interventional

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

NCT ID: NCT02148302 Terminated - Clinical trials for Venous Insufficiency of Leg

Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers

Cellutome
Start date: May 2014
Phase: N/A
Study type: Interventional

Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). 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. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.