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Leg Ulcer clinical trials

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NCT ID: NCT01964911 Completed - Clinical trials for Hypertensive Leg Ulcer

To Assess Analgesia Provided by Continuous Sciatic Nerve Block in Patients With Hypertensive Leg Ulcer

ANGIOCATH
Start date: February 2014
Phase: Phase 4
Study type: Interventional

Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia. This is why pain management is one of the main challenge in treatments of these ulcers. Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation. The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization. Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days. Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment. The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne. Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.

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: NCT01913704 Withdrawn - Clinical trials for Skin Ulcer Venous Stasis Chronic

Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

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

The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.

NCT ID: NCT01903044 Active, not recruiting - Diabetic Foot Clinical Trials

Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

NCT ID: NCT01891760 Completed - Venous Leg Ulcer Clinical Trials

Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

LTFU
Start date: May 2010
Phase: Phase 3
Study type: Interventional

- Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study. - Study Hypothesis: N/A (Long-term follow-up study)

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: NCT01801891 Completed - Clinical trials for Chronic Venous Disease

Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers

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

This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression bandaging accelerates the rate of venous leg ulcer healing.

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.