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Ulcer clinical trials

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NCT ID: NCT02585765 Withdrawn - Spinal Cord Injury Clinical Trials

Skin Blood Flow Response to Insulin Iontophoresis in Pressure Ulcers of SCI

Start date: February 1, 2017
Phase: Phase 2
Study type: Interventional

Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. Among the numerous potential physical risk factors identified for the development of a PU were several conditions that have a significant negative effect on skin blood flow. In addition, improper management of blood sugar is a major risk factor for PU development and it impedes healing. It would appear that hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that target the blood vessels may play an important role in the development and formation of a PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the lower extremity were shown to be much lower than healthy individuals. The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic region PU has 2 phases: (1) a 4-week "observation" phase [if the PU does not heal appropriately (determined by digital photos and software computation), and the subject is found to be insulin resistant then they will progress to the next phase of the study] and (2) an 8-week "treatment" phase. All participants will continue to receive the standard wound care throughout the observation and treatment phases. If the surface area of the PU does not decrease by more than 30% during the 4-week observation phase, the participant will be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to receive active drug (e.g., pioglitazone) or placebo. The participants will have four study visits in which the following will be acquired: digital image of the wound to monitor wound surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional status (albumin and pre-albumin), a complete blood count with differential, and makers of inflammation. Weekly monitoring of symptoms and participant experiences will be closely monitored.

NCT ID: NCT02583958 Recruiting - Leg Ulcers Clinical Trials

Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

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

Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.

NCT ID: NCT02581488 Completed - Diabetic Foot Clinical Trials

Use of Santyl in Diabetic Foot Ulcers

Start date: October 2015
Phase: Phase 4
Study type: Interventional

This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.

NCT ID: NCT02581098 Completed - Diabetes Mellitus Clinical Trials

miR-200b & miR-21 in Diabetic Wounds

Start date: August 2015
Phase:
Study type: Observational

This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.

NCT ID: NCT02579733 Terminated - Ulcerative Colitis Clinical Trials

Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

ACE
Start date: February 1, 2016
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

NCT ID: NCT02578004 Completed - Pressure Ulcers Clinical Trials

Risk Factors for Pressure Ulcers

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

Development of pressure ulcer (PU) is complex and multifactorial. The association of a constituted PU and of clinical / biological major elements is demonstrated and justifies. Prevention of PU is an important health priority, one that requires clear identification of risk factors.

NCT ID: NCT02577120 Suspended - Clinical trials for Diabetic Foot Ulcers

Wound Healing Endpoint and Recurrence

Start date: January 8, 2019
Phase: Phase 4
Study type: Interventional

This prospective pilot study is to enroll patients with clinically-defined infected wounds. Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients will be recruited for this study in Phase A. Based on the expectation that 89% of these wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the study for Phase B.

NCT ID: NCT02571738 Terminated - Clinical trials for Chronic Diabetic Foot Ulcers

Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers

*OTI-15-01
Start date: October 2015
Phase: Phase 3
Study type: Interventional

A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

NCT ID: NCT02570321 Recruiting - Corneal Ulcer Clinical Trials

Cross-linking for Corneal Ulcers Treatment Trial

CLAIR
Start date: November 2015
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.

NCT ID: NCT02569333 Completed - Clinical trials for Inflammatory Bowel Diseases

Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis

PATIENT-UC
Start date: January 2016
Phase: N/A
Study type: Interventional

Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of complications such as infections, venous thrombosis, and surgery. The literature has revealed significant variation in the quality of care to hospitalized UC patients. As a result, guidelines for the management of these patients have been developed. However, the update of guidelines are variable. Admission to hospital can also have significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease. Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic diseases. The investigators propose the development of a multi-site, patient centred initiative aimed at improving clinical and patient-centered outcomes through an educational iPad based tool for patients admitted to hospital with ulcerative colitis.