MedTrace Logo

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

NCT07783087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-09-03

No results posted yet for this study

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

Conditions

  • Diabetic Foot Ulcer (DFU)

Interventions

DEVICE

VES-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

DEVICE

Standard of Care (Investigator Choice)

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

Sponsors & Collaborators

  • Flen Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-08-31
Completion
2027-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783087 on ClinicalTrials.gov