An interventional study of VES-0-D wound gel and Standard of Care (Investigator Choice) in Diabetic Foot Ulcer (DFU), sponsored by Flen Health. Recruiting at 8 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Flen Health · Not applicable, Interventional, and Treatment
Among 10 studies in Diabetic Foot with a site in Belgium — 1 open to participants now, 1 under way, none of them phase 3. Diabetic Foot · Belgium.
Among the 10 studies in Diabetic Foot with a site in Belgium, this one is the 8th largest by planned enrollment, is the only one that started in 2026, is one of 4 with no phase, and was the 10th registered.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →1 of the 10 studies in Diabetic Foot with a site in Belgium is open now.
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 6
First in 2006; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 64 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Median enrollment 200 across the 10 interventional studies. Of the 8 that completed or were terminated, 6 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 10 have an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with Flen Health as lead sponsor.
Flen Health has 1 study filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetic Foot with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07783087Flen HealthA Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers | 2027-08 |
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Among the 10 studies in Diabetic Foot with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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 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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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)
VES-0-D Gel is a non-invasive topical medical device intended to manage moisture levels at the surface of open wounds
Standard of care wound dressing will be chosen by the treating physician
Percent wound area reduction from baseline at the end of 8 weeks in VES-0-D Gel vs. Standard Care-treated subjects
Time frame: From enrollment to the end of treatment at 8 weeks
Changes from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) (Bates-Jensen 2019)
The Bates-Jensen Wound Assessment Tool (BWAT) uses a list of 13 questions to come up with a result between 13 and 60 points. Higher points reflect a worse outcome (degeneration of the wound).
Time frame: From enrollment to the end of treatment at 8 weeks
Number and nature of treatment-emergent adverse events
Time frame: From enrollment to the end of treatment at 8 weeks
Not enrolling at this site.
Plan to share: Yes
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 103 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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