RecruitingNot ApplicableNCT07783087

A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers

A Multicenter, Randomized Controlled Trial of VES-0-D Gel, an Investigational Alginol, Versus Standard Care in the Management of Wagner Grade 1 or 2 Diabetic Foot Ulcers Over 8 Weeks


Sponsor

Flen Health

Enrollment

64 participants

Start Date

Aug 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers. The main question it aims to answer is: How well does VES-0-D gel support wound healing, compared with a standard wound treatment? Other questions that are the target of the investigation are: * the evaluation of wound characteristics relevant to healing * the evaluation of side effects at the site of application The investigation will compare the wound area reduction over the 8 week treatment for VES-0-D vs standard of care treated patients. The investigation will also collect wound assessment scoring results over the entire study duration as well as safety data on VES-0-D. Participants will: Have VES-0-D or standard of care applied every 3-4 days for 8 weeks, either at home or in the clinic Visit the clinic once every week for checkups and assessments. Keep a diary of their applications and any symptoms they might experience


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Standard of Care (Investigator Choice) and a medical device called VES-0-D wound gel for people with diabetic foot ulcer (dfu). The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVES-0-D wound gel

VES-0-D Gel is a non-invasive topical medical device intended to manage moisture levels at the surface of open wounds

DEVICEStandard of Care (Investigator Choice)

Standard of care wound dressing will be chosen by the treating physician


Locations(8)

Imeldaziekenhuis

Bonheiden, Antwerp, Belgium

AZ Sint-Maarten

Mechelen, Antwerp, Belgium

UZ Gent

Ghent, East-Flanders, Belgium

Grand Hôpital de Charleroi - Les Viviers

Charleroi, Henegouwen, Belgium

CHU de Liège - Sart Tilman

Liège, Liège, Belgium

Hôpital d'Arlon - Vivalia

Arlon, Luxemburg, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Sint-Lucas

Bruges, West-Vlaanderen, Belgium

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NCT07783087


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