Wound gel for diabetic foot ulcers compared with standard care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional study comparing the VES-0-D wound gel to standard wound care in adults with diabetes and mild to moderate diabetic foot ulcers. Participants will apply either VES-0-D or standard care every 3–4 days for 8 weeks, with weekly clinic visits and daily application diaries. The trial measures wound area reduction over 8 weeks, along with wound healing characteristics, adverse events at the application site, and safety data. Eligibility targets adults with diabetes, an index ulcer in a specified plantar region, and adequate blood flow to the foot, among other criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subject has signed an IEC-approved study informed consent form
2. The subject is male or female, at least 18 years of age at the date of screening
3. The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
4. The subject has a body mass index (BMI) of less than 40 kg/m2
5. 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
6. The index ulcer has been present for less than 12 months
7. The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot
8. The index ulcer does not extend beyond the subcutaneous tissue
9. 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.
10. The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test.
11. The subject is willing and able to return for all mandatory visits as defined in the protocol
12. The subject is willing and able to follow the instructions of the Investigator

Exclusion Criteria:

1. The subject's index ulcer is primarily located on the dorsal surface of the foot
2. The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation
3. The subject has a contralateral major amputation of the lower extremity
4. 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)
5. The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved)
6. The subject has a glycated hemoglobin (HbA1c) level of \> 8.0% (historical data may be used from within 6 months prior to screening)
7. The subject has been on oral steroid \> 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening
8. The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening
9. The subject is unable to sustain off-loading as defined by the protocol
10. The subject has an allergy to any component of the test article
11. The index ulcer is over an acute Charcot deformity
12. 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)
13. Per Investigator's discretion the subject is not appropriate for inclusion in the investigation
14. Female patients who are pregnant or lactating

Where it's running

• Imeldaziekenhuis
  Bonheiden, Antwerp, Belgium Recruiting
• AZ Sint-Maarten
  Mechelen, Antwerp, Belgium Active not recruiting
• UZ Gent
  Ghent, East-Flanders, Belgium Not yet recruiting
• Grand Hôpital de Charleroi - Les Viviers
  Charleroi, Henegouwen, Belgium Not yet recruiting
• CHU de Liège - Sart Tilman
  Liège, Liège, Belgium Not yet recruiting
• Hôpital d'Arlon - Vivalia
  Arlon, Luxemburg, Belgium Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Coordinated primary-care MDT approach for hard-to-heal ulcers

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• CAMPR-II: A real-world look at a membrane wrap or a polymer wound matrix for hard-to-heal foot ulcers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.