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Ulcer clinical trials

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NCT ID: NCT02236793 Completed - Diabetic Foot Ulcer Clinical Trials

A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).

NCT ID: NCT02229344 Completed - Colitis, Ulcerative Clinical Trials

Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea

MOSAIK
Start date: July 1, 2014
Phase:
Study type: Observational

The purpose of this study is to describe clinical course of newly diagnosed moderate to severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral hospitals in Korea for 5-year follow-up under usual care.

NCT ID: NCT02227342 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

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

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

NCT ID: NCT02224742 Completed - Diabetic Foot Ulcer Clinical Trials

LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

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

Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patient's own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal. This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch comprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the United Kingdom, Denmark and Sweden.

NCT ID: NCT02224638 Completed - Pressure Ulcers Clinical Trials

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

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

Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

NCT ID: NCT02224404 Completed - Pressure Ulcers Clinical Trials

Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

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

The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).

NCT ID: NCT02222506 Completed - Clinical trials for Diabetic Foot Ulcers

Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers

Start date: April 2013
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 diabetic foot ulcers.

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: NCT02222454 Completed - Clinical trials for Pressure Ulcers Stage III

Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure 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 stage II or III pressure ulcers.

NCT ID: NCT02222376 Completed - Clinical trials for Diabetic Foot Ulcers

Effect of Topic Pirfenidone in Diabetic Ulcers

PirDFI
Start date: October 2013
Phase: Phase 3
Study type: Interventional

Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and vascular endothelial growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties. The aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers. The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. This is a randomized, controlled and crossover study. Patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this period they will change groups. Each week ulcers will be for size, depth, length and evidence of infection. The ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.