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Ulcer clinical trials

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NCT ID: NCT02825914 Completed - Clinical trials for Inflammatory Bowel Diseases

CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

CAGLUCIM
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.

NCT ID: NCT02819635 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: September 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

NCT ID: NCT02818686 Completed - Clinical trials for Ulcerative Colitis, Active Moderate

TD-1473 for Active Ulcerative Colitis (UC)

Start date: October 3, 2016
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

NCT ID: NCT02818543 Completed - Ulcerative Colitis Clinical Trials

Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis

Start date: March 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.

NCT ID: NCT02801305 Completed - Clinical trials for Digital Ulcer of Scleroderma

Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

Start date: June 2016
Phase: Phase 2
Study type: Interventional

Digital ulcers are one of the most prevalent complications of scleroderma (systemic sclerosis). There can be found few surveys on effect of topical agents on healing process of the ulcers. Thus, the aim of this study is to assess and compare the effects of topical diltiazem on SSc digital ulcers versus topical nitroglycerin.

NCT ID: NCT02800993 Completed - Systemic Sclerosis Clinical Trials

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

RAPIDS-2
Start date: October 2003
Phase: Phase 3
Study type: Interventional

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

NCT ID: NCT02799121 Completed - Diabetic Foot Ulcer Clinical Trials

A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

Start date: May 2016
Phase: Phase 4
Study type: Interventional

This prospective case series is to gain additional clinical experience in the treatment of diabetic foot ulcers, by documenting and relating patient history (including baseline wound characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient and physician satisfaction) in a group of study participants for whom the ReGenerCell™ Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings, offloading).

NCT ID: NCT02798055 Completed - Scleroderma Clinical Trials

Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis

GRegistry SCDU
Start date: September 30, 2016
Phase:
Study type: Observational [Patient Registry]

GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers. The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country. The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.

NCT ID: NCT02789800 Completed - Stroke Clinical Trials

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

PACEinMM-QC
Start date: April 22, 2016
Phase: N/A
Study type: Interventional

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

NCT ID: NCT02789033 Completed - Clinical trials for Diabetic Foot Ulcers

Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers

Start date: June 2015
Phase: Phase 3
Study type: Interventional

The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition is more frequent in elder patients. It is estimated that about 5% of all patients with diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while 10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb amputation could also be involved in a new amputation in the next year; higher or in the other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading device, wound care and surgery in selected cases. However, treatment of DFU remains challenging because of unsatisfactory results from surgical and non-surgical treatments. Many adjunctive therapies are designed to improve the care of DFU including negative pressure wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB) Hyperbaric oxygen and acellular matrix product among others.