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Ulcer clinical trials

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NCT ID: NCT03404895 Recruiting - Diabetes Clinical Trials

The Mount Sinai Diabetic Foot Ulcer Prospective Trial

Start date: April 13, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.

NCT ID: NCT03404557 Completed - Ulcerative Colitis Clinical Trials

Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC

ROMAN
Start date: January 18, 2018
Phase:
Study type: Observational

The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages. That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.

NCT ID: NCT03404297 Completed - Kaposi Sarcoma Clinical Trials

Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The efficacy of locally sourced compression therapy in the management of chronic leg ulcers and Kaposi Sarcoma in western Kenya will be studied in a rural setting

NCT ID: NCT03398538 Completed - Diabetic Foot Ulcer Clinical Trials

Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Start date: December 26, 2017
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

NCT ID: NCT03398148 Completed - Clinical trials for Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

NCT ID: NCT03398135 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Start date: August 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

NCT ID: NCT03396731 Completed - Venous Leg Ulcer Clinical Trials

Efficacy Study for Geko Device in VLU Patients

Start date: April 24, 2018
Phase: N/A
Study type: Interventional

Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase). To compare two daily geko™ device treatment durations, six hours and 12 hours, in conjunction with SC, with each other and to SC alone, in patients with venous leg ulcers

NCT ID: NCT03394586 Recruiting - Ulcerative Colitis Clinical Trials

Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

Start date: January 1, 2018
Phase: N/A
Study type: Observational [Patient Registry]

TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of our study to test, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland. The investigators will use data from the Swiss IBD cohort study (SIBDC) in Switzerland. They will identify all SIBDC patients with UC treated with Golimumab and perform a retrospective chart review. The investigators will acquire patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint will be clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints will be clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).

NCT ID: NCT03391310 Completed - Pressure Ulcer Clinical Trials

Use of Honey for Pressure Ulcers in Critically Ill Children

Start date: September 2, 2017
Phase: N/A
Study type: Interventional

The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

NCT ID: NCT03378388 Terminated - Crohn Disease Clinical Trials

A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life

GEVOL
Start date: February 13, 2018
Phase:
Study type: Observational

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.