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

NCT07783087 | Recruiting

• 2 other identifiers: FLEN-VES-0-D-GEL-101CIV-26-02-056699
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

Brief 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)

Keywords

Diabetic Foot Ulcer; Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent wound area reduction from baseline at the end of 8 weeks in VES-0-D Gel vs. Standard Care-treated subjects

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Changes from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) (Bates-Jensen 2019)

  From enrollment to the end of treatment at 8 weeks

• Number and nature of treatment-emergent adverse events

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

VES-0-D

EXPERIMENTAL

Investigational Wound Gel consisting primarily of an alginate and hydrogel component. Application will be performed every 3-4 days for 8 weeks or until wound closure.

Device: VES-0-D wound gel

Standard of Care

ACTIVE COMPARATOR

Standard care primary dressing will be chosen at the physicians discretion. Application will be performed every 3-4 days for 8 weeks or until wound closure.

Device: Standard of Care (Investigator Choice)

Interventions

VES-0-D wound gel DEVICE

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

VES-0-D

Standard of Care (Investigator Choice) DEVICE

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has signed an IEC-approved study informed consent form
• The subject is male or female, at least 18 years of age at the date of screening
• The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
• The subject has a body mass index (BMI) of less than 40 kg/m2
• The subject has an index ulcer with visible margins, having an area of ≥ 0.5 and ≤ 10.0 cm2 when measured by the electronic measuring device at screening
• The index ulcer has been present for less than 12 months
• The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot
• The index ulcer does not extend beyond the subcutaneous tissue
• The subject has an ABI \> 0.6 to \< 1.3 or TcPO2 ≥ 40 mmHg on the dorsum of the affected foot, or a great toe pressure ≥ 50 mmHg on the affected foot. Duplex ultrasound of the lower limb arteries is an acceptable alternative test but must show a peak systolic velocity ratio of \<2 for at least one of the posterior tibial, dorsalis pedis, and peroneal arteries.
• The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test.
• The subject is willing and able to return for all mandatory visits as defined in the protocol
• The subject is willing and able to follow the instructions of the Investigator

You may not qualify if:

• The subject's index ulcer is primarily located on the dorsal surface of the foot
• The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation
• The subject has a contralateral major amputation of the lower extremity
• The subject has more than 2 ulcers on the index foot (if there are two ulcers, the larger will be chosen as the index ulcer for treatment)
• The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved)
• The subject has a glycated hemoglobin (HbA1c) level of \> 8.0% (historical data may be used from within 6 months prior to screening)
• The subject has been on oral steroid \> 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening
• The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening
• The subject is unable to sustain off-loading as defined by the protocol
• The subject has an allergy to any component of the test article
• The index ulcer is over an acute Charcot deformity
• The subject is a member of a vulnerable population (e.g., prisoner, employee or family member of Sponsor or site staff, minor child, significant intellectual deficit)
• Female patients who are pregnant or lactating

Sponsors & Collaborators

• Flen Health: lead

Study Sites (4)

Imeldaziekenhuis

Bonheiden, Antwerp, 2820, Belgium

RECRUITING

AZ Sint-Maarten

Mechelen, Antwerp, 2800, Belgium

ACTIVE NOT RECRUITING

CHU de Liège - Sart Tilman

Liège, Liège, 4000, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (4)