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Ulcer clinical trials

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NCT ID: NCT05234632 Terminated - Pressure Ulcer Clinical Trials

Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds

PICO14
Start date: September 22, 2020
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, open label study evaluating the performance of PICO14 NPWT in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO. The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.

NCT ID: NCT05181644 Terminated - Scleroderma Clinical Trials

Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

SUITABLE
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

NCT ID: NCT05057793 Terminated - Venous Leg Ulcer Clinical Trials

Efficacy Study for Geko Device in VLU Patients (Canada)

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go through a four-week run-in phase, followed by a four-week treatment phase and a three-month long term follow-up.

NCT ID: NCT04985968 Terminated - Ulcerative Colitis Clinical Trials

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

CONCLUDE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

NCT ID: NCT04968951 Terminated - Ulcerative Colitis Clinical Trials

Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

REFOCUS
Start date: November 10, 2021
Phase: Early Phase 1
Study type: Interventional

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

NCT ID: NCT04850313 Terminated - Clinical trials for Bacterial Corneal Ulcer

Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

Start date: November 9, 2021
Phase: N/A
Study type: Interventional

The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.

NCT ID: NCT04838600 Terminated - Chronic Leg Ulcer Clinical Trials

A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®

ChloraSolv02
Start date: June 7, 2021
Phase:
Study type: Observational

This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.

NCT ID: NCT04696354 Terminated - Venous Ulcer of Leg Clinical Trials

Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)

IGuideU
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).

NCT ID: NCT04677179 Terminated - Colitis, Ulcerative Clinical Trials

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

INSTRUCT-UC
Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

NCT ID: NCT04634838 Terminated - Diabetic Foot Ulcer Clinical Trials

Efficacy of Wound Dressings With Copper Oxide

Start date: February 2, 2021
Phase: N/A
Study type: Interventional

Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.