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Leg Ulcer clinical trials

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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.

NCT ID: NCT01319123 Completed - Clinical trials for Moderatley to Highly Exuding Venous Leg Ulcers

Evaluate the Impact of Drawtex in Venous Leg Ulcers

Start date: October 2010
Phase: N/A
Study type: Interventional

This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.

NCT ID: NCT01316796 Completed - Sickle Cell Disease Clinical Trials

Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders

Start date: March 15, 2011
Phase: Phase 1
Study type: Interventional

Background: - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease, thalassemia, and other red blood cell disorders. In these disorders, red blood cells break down earlier than normal, which researchers suspect may cause or contribute to the development of leg ulcers; however, the exact cause is unknown, and current therapies are not very effective. Researchers are interested in determining if a research cream made with sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels, may speed up the healing of skin ulcers. Objectives: - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders. Eligibility: - Individuals at least 18 years of age who have sickle cell disease or another red cell disorder and have had a leg ulcer for more than 4 weeks. Design: - Participants will be screened with a physical examination, medical history, blood tests, and an examination of the ulcer, including x-ray of the leg(s) with the ulcer and swabs from the wound. - Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with the following procedures: - Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the affected leg, imaging studies (magnetic resonance imaging and infrared photography), thermo-patch application to monitor temperature changes, measurements of blood flow in the skin, and questionnaires about pain and quality of life. An optional skin biopsy may also be conducted with samples taken near the skin ulcer - Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood draws will be conducted before application and then regularly for up to 6 hours after application of the cream. Thirty minutes after the research cream is applied, participants will have imaging studies of the treated leg and measurements of pain levels and blood flow. - Day 4: Participants will have a blood draw and temperature recordings taken. - Day 5: Participants will have the research cream applied and the same imaging studies as before, and will be discharged for care at home. - For the following 3 weeks, participants will come to the clinical center twice a week to have the research cream applied to the leg ulcer and tests performed by the study researchers. - For the fourth and final week, participants will return for additional cream treatment sessions, imaging studies, blood draws, and other tests as directed by the study researchers. - Study participation will end in the following week (week 5). Subjects will come for a final visit one month after the end of the study.

NCT ID: NCT01249495 Recruiting - Clinical trials for Proinflammatory Cytokines

Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.

NCT ID: NCT01238419 Completed - Leg Ulcers Clinical Trials

Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Start date: November 2009
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

NCT ID: NCT01199588 Completed - Venous Leg Ulcers Clinical Trials

A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers

NOVEL2
Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.

NCT ID: NCT01153633 Completed - Venous Leg Ulcer Clinical Trials

Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel

Start date: October 2009
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.

NCT ID: NCT01138436 Completed - Ulcers Clinical Trials

A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

NCT ID: NCT01111695 Completed - Leg Ulcer Clinical Trials

Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

Start date: January 2010
Phase: Phase 2
Study type: Interventional

In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data. The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.

NCT ID: NCT01084577 Completed - Leg Ulcer Clinical Trials

AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Start date: January 2010
Phase: Phase 4
Study type: Interventional

A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.