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Ulcer clinical trials

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NCT ID: NCT04677166 Recruiting - Burns Clinical Trials

Coupling Negative Pressure Wound Therapy With Instillation

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.

NCT ID: NCT04659148 Recruiting - Ulcerative Colitis Clinical Trials

Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer

UC-RectalK
Start date: October 1, 2020
Phase:
Study type: Observational

This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.

NCT ID: NCT04653259 Recruiting - Ulcerative Colitis Clinical Trials

Digital Nutrition Therapy for Patients With IBD

LYFEMD
Start date: May 15, 2021
Phase: N/A
Study type: Interventional

Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and intestinal failure. Ascend is a collaboration of excellence within the Department of Medicine, Division of Gastroenterology at both the University of Calgary and University of Alberta. Dr. Raman, PI, is the Director of Ascend. One of Ascend's primary initiatives is the development of a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman's team, and exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free. In addition to delivering personalized and interactive support, the app uses behavior science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. With proprietary research and a team made up of internationally recognized leaders in the gastrointestinal field, LyfeMD is poised to be the trusted digital health solution for people living with IBD.

NCT ID: NCT04647240 Recruiting - Venous Leg Ulcer Clinical Trials

Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Start date: February 26, 2022
Phase: Phase 2
Study type: Interventional

DL-VSU-201 is a randomized, double-blind, placebo controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of Dermacyte® Amniotic Wound Care Liquid (Dermacyte® Liquid).

NCT ID: NCT04624230 Recruiting - Ulcerative Colitis Clinical Trials

Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis

Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

NCT ID: NCT04614870 Recruiting - Diabetic Foot Ulcer Clinical Trials

DETEC® Esterase for Screening Wound Infection at Point of Care

Start date: May 1, 2022
Phase:
Study type: Observational

This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.

NCT ID: NCT04614038 Recruiting - Diabetic Foot Ulcer Clinical Trials

DETEC® pH Point of Care Wound Diagnostic Test

Start date: January 1, 2022
Phase:
Study type: Observational

The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.

NCT ID: NCT04591691 Recruiting - Diabetes Clinical Trials

C-myc Biomarker Study for Diabetic Foot Ulcers

Start date: October 14, 2020
Phase:
Study type: Observational

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

NCT ID: NCT04573647 Recruiting - Clinical trials for Neurotrophic Keratitis

OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Start date: October 1, 2020
Phase:
Study type: Observational

Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.

NCT ID: NCT04569409 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.