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Ulcer clinical trials

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NCT ID: NCT02565797 Completed - Pressure Ulcer Clinical Trials

Comparative Prevention-effectiveness Trial of DabirAIR Overlay System

Start date: November 2015
Phase: N/A
Study type: Interventional

Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge.

NCT ID: NCT02565745 Terminated - Pressure Ulcer Clinical Trials

Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized Trial

PENFUP
Start date: December 2015
Phase: Phase 3
Study type: Interventional

Study purpose: To assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital PU

NCT ID: NCT02565264 Enrolling by invitation - Ulcer Clinical Trials

Effect of Plasma Derived Exosomes on Cutaneous Wound Healing

Start date: September 2015
Phase: Early Phase 1
Study type: Interventional

This study is an open prospective clinical trial. The objective is to evaluate the effect of autologous exosomes rich plasma on cutaneous wound healing. The participants are patients with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns). The participants will be treated autologous exosomes rich plasma every day for 28 days. The cutaneous wound healing will be evaluated by the length, width and depth of the wound.

NCT ID: NCT02563522 Terminated - Clinical trials for Foot Ulcer, Diabetic

Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers

Start date: June 27, 2017
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.

NCT ID: NCT02561013 Withdrawn - Varicose Ulcer Clinical Trials

A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers.

NCT ID: NCT02559713 Completed - Crohn's Disease Clinical Trials

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

Start date: November 29, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

NCT ID: NCT02554851 Active, not recruiting - Clinical trials for Foot Ulcer, Diabetic

Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer.

Start date: January 2017
Phase: Phase 3
Study type: Interventional

Phase III clinical trial, multicenter, controlled, randomized, double-blind, with two parallel groups (experimental and control). Both study groups will receive standard therapy currently available in treatment centers for diabetic foot ulcer (DFU). Associate with the standard therapy, it will be given the recombinant human Epidermal Growth Factor (rhEGF) to experimental group and in the control group, it will be given a formulation without pharmacological effect (placebo) in order to masking and control of intralesional application. Participants with type 1 and type 2 diabetes mellitus (DM) diagnosed with DFU for at least 4 weeks, treated in referral centers participating in the study, agreeing to participate after reading, understanding and signing of Informed Consent (IC); meet all the inclusion criteria; and presenting no exclusion criteria. The Informed Consent (IC) should be applied to potential participants, as recommended by the regulations and ethical consensus before beginning any procedure related to the clinical trial. In the early weeks, participants will be evaluated at the research centers by the study team (doctors and / or staff). The number of visits will be determined by the investigator, thus ensuring appropriate assistance to participants, and avoiding any complications with DFU. By meeting the eligibility requirements (inclusion and exclusion criteria), the participant will undergo a thorough evaluation of the DFU before the start of treatment. This assessment is precisely to classify the condition of the ulcer before treatment and provide relevant information for statistical analysis of the protocol. If eligible, the participant will be randomly set to treatment arm (placebo or rhEGF) and the administration of investigational product associated with predefined standardized outpatient therapy will be initiated. This administration occurs three times per week until the DFU is scarred, not exceeding 8 weeks of treatment (T.01 to T.08) .The study will be randomized and balanced according to the type and size of the DFU. This balancing is necessary to ensure that both treatment groups are homogeneous for participants under different conditions. All participants will be applied established standard therapy for the treatment of DFU. The objective is to provide regular care for healing and reduce possible bias in the efficacy analysis and product safety. After the treatment period (last dose of the experimental drug) the participant will start the follow-up period, with 16 weeks duration. The participant shall be subjected to weekly visits for ongoing assessment of DFU, however, according to the investigator, may result in unscheduled visits to assess local or general clinical events. After the monitoring period, the participant will be observed for 24 additional weeks, visits every 4 weeks (E.01 E.24 a) having beginning one week after the last visit of follow-up. This period is intended to assess possible events related to the efficacy and safety that can happen in the period, mainly for analysis of secondary endpoints.

NCT ID: NCT02551744 Completed - Peptic Ulcer Clinical Trials

Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

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

Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.

NCT ID: NCT02550418 Completed - Colitis, Ulcerative Clinical Trials

Budesonide 9 mg Capsules in Active UC

TOPICAL-1
Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

NCT ID: NCT02537210 Completed - Colitis, Ulcerative Clinical Trials

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.