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Leg Ulcer clinical trials

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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.

NCT ID: NCT01966380 Terminated - Diabetic Foot Ulcer Clinical Trials

Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.

NCT ID: NCT01957124 Terminated - Clinical trials for Hypertensive Leg Ulcer

Treatment of the Hypertensive Leg Ulcers by PRF Application

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established. We want to study the efficacy of PRF applications on the pains related to those ulcers. PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation. PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot. The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.

NCT ID: NCT01954901 Terminated - Clinical trials for Wagner Grade 2 Lower Extremity Ulcers

Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

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

The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.

NCT ID: NCT01853384 Terminated - Ulcer Clinical Trials

Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

NCT ID: NCT01817543 Terminated - Venous Leg Ulcer Clinical Trials

A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

Start date: October 2013
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, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)

NCT ID: NCT01657318 Terminated - Diabetic Foot Clinical Trials

Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers

Start date: September 1, 2012
Phase:
Study type: Observational

In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.

NCT ID: NCT01612806 Terminated - Venous Stasis Ulcer Clinical Trials

A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers

Start date: June 2011
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

NCT ID: NCT01396304 Terminated - Infection Clinical Trials

Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.