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Leg Ulcer clinical trials

View clinical trials related to Leg Ulcer.

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NCT ID: NCT05610241 Completed - Venous Leg Ulcer Clinical Trials

Preliminary Investigation of a Smart Compression Therapy Prototype

PRESUF-VLU
Start date: March 4, 2023
Phase: N/A
Study type: Interventional

Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.

NCT ID: NCT05608317 Recruiting - Venous Leg Ulcer Clinical Trials

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Start date: November 8, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

NCT ID: NCT05588583 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

NCT ID: NCT05570877 Recruiting - Diabetic Foot Ulcer Clinical Trials

ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

CHITOCHRONIC
Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.

NCT ID: NCT05564728 Completed - Clinical trials for Diabetes Mellitus, Type 2

Diabetes Footcare Companion App for Patients and Carers

Start date: June 23, 2023
Phase:
Study type: Observational

Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. By utilizing feedback and responses to evaluative questions posted on the app's interface, the investigators intend to examine the app's technical, functional, and operational feasibility.

NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05549609 Recruiting - Venous Leg Ulcer Clinical Trials

A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers

Start date: October 26, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care. The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.

NCT ID: NCT05494450 Terminated - Diabetic Foot Ulcer Clinical Trials

An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds

NCT ID: NCT05489588 Recruiting - Venous Leg Ulcer Clinical Trials

The GORE® VIAFORT Vascular Stent Iliofemoral Study

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.

NCT ID: NCT05422248 Recruiting - Chronic Leg Ulcer Clinical Trials

Oxygen Wound Therapy Feasibility Study

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.