Diabetic Foot Ulcer (DFU)AIM-DFUNCT07783087
A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers
A study testing VES-0-D wound gel in people with Diabetic Foot Ulcer (DFU), run by Flen Health at 8 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- VES-0-D wound gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesBelgium
- Study dates
- 10 Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
- Per Investigator's discretion the subject is not appropriate for inclusion in the investigation
- Female patients who are pregnant or lactating
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Belgium8 sites, 7 recruiting
- Not yet recruiting
Hôpital d'Arlon - Vivalia
Arlon, Luxemburg, 6700
- Recruiting
Imeldaziekenhuis
Bonheiden, Antwerp, 2820
xxxxxxxxxx@xxx.com
- Not yet recruiting
AZ Sint-Lucas
Bruges, West-Vlaanderen, 8310
- Not yet recruiting
Grand Hôpital de Charleroi - Les Viviers
Charleroi, Henegouwen, 6060
- Not yet recruiting
UZ Gent
Ghent, East-Flanders, 9000
- Not yet recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
xxxxxxxxxxxx, xxxxxxxxxxxx@xxxxx.be
- Not yet recruiting
CHU de Liège - Sart Tilman
Liège, Liège, 4000
xxxxxxxxx@xxx.be
- Active, not recruiting
AZ Sint-Maarten
Mechelen, Antwerp, 2800
About this study
Official title: 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
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:
Read more
- 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)
- Being tested
- VES-0-D wound gel, Standard of Care (Investigator Choice)
- Keywords
- Diabetic Foot Ulcer, Diabetes
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VES-0-D wound gelDevice
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 (Investigator Choice)Device
Standard of care wound dressing will be chosen by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent wound area reduction from baseline at the end of 8 weeks in VES-0-D Gel vs. Standard Care-treated subjects
Measured: 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)
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).
Measured: From enrollment to the end of treatment at 8 weeks
Number and nature of treatment-emergent adverse events
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start10 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flen Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783087
- Sponsor's protocol ID
- FLEN-VES-0-D-GEL-101
- Other IDs
- CIV-26-02-056699
- Acronym
- AIM-DFU
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07783087
- Acronym / sponsor ID
- AIM-DFU / FLEN-VES-0-D-GEL-101
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Diabetic Foot Ulcer, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Flen HealthIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VES-0-D | Experimental | Device: VES-0-D wound gelInvestigational 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. |
| Standard of Care | Active comparator | Device: Standard of Care (Investigator Choice)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VES-0-D wound gelVES-0-D Gel is a non-invasive topical medical device intended to manage moisture levels at the surface of open wounds | Device | VES-0-D |
| Standard of Care (Investigator Choice)Standard of care wound dressing will be chosen by the treating physician | Device | Standard of Care |
Primary outcome
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
2 secondary outcomes
Changes from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) (Bates-Jensen 2019)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VES-0-D wound gel in people with Diabetic Foot Ulcer (DFU), run by Flen Health at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.