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NCT ID: NCT01982565 Completed - Diabetic Foot Ulcer Clinical Trials

Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

ProNOx1
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic DFUs compared to standard of care.

NCT ID: NCT01971814 Completed - Clinical trials for Inflammatory Bowel Disease

Early Serum Infliximab Levels in Severe Ulcerative Colitis.

EaSiFx
Start date: November 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.

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: NCT01964521 Completed - Clinical trials for Diabetic Foot Ulcers

TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended

MxT Ag 05
Start date: February 2014
Phase: N/A
Study type: Interventional

An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.

NCT ID: NCT01964131 Completed - Gastric Ulcer Clinical Trials

BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

NCT ID: NCT01960439 Completed - Ulcerative Colitis Clinical Trials

Responsiveness of Endoscopic Evaluation in UC

Start date: July 2013
Phase: N/A
Study type: Observational

The purpose of this study of this study is to assess the responsiveness and validity of CIMS (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis) clinical disease activity by measuring: The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in UC.

NCT ID: NCT01959282 Completed - Colitis, Ulcerative Clinical Trials

A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: November 15, 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT01959165 Completed - Ulcerative Colitis Clinical Trials

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Start date: November 21, 2013
Phase: Phase 2
Study type: Interventional

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

NCT ID: NCT01957930 Completed - Ischemic Foot Ulcer Clinical Trials

Intensive Insulin Treatment and Ischemic Foot Ulcer

Start date: January 1984
Phase: N/A
Study type: Interventional

We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).

NCT ID: NCT01956162 Completed - Clinical trials for Foot Ulcer, Diabetic

Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

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

Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers. - Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.