Assessing the effectiveness of Berovenal® for healing diabetic foot ulcers

A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer

This study is testing if the Berovenal® device can help heal diabetic foot ulcers in adults with diabetes over eight weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: VULM s.r.o. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Kösching, Eichstatt and 8 other locations)
• Trial ID: NCT06584617 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the efficacy and safety of the medical device Berovenal® in promoting the healing of chronic diabetic foot ulcers in adults aged 18-85 with diabetes mellitus. Participants will use Berovenal® or a reference device daily for 8 weeks while attending bi-weekly clinic visits for assessments. The study will measure the reduction in ulcer size and monitor any medical issues arising from the use of the device. The goal is to create a moist environment that mimics the intracellular conditions of damaged tissue to expedite healing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with type 1 or type 2 diabetes and a chronic diabetic foot ulcer that meets specific criteria.

Not a fit: Patients with known contraindications to hydrogel dressings or those whose ulcers are showing significant improvement prior to randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic diabetic foot ulcers.

How similar studies have performed: Other studies have shown promise in using similar hydrogel approaches for wound healing, suggesting potential for success in this investigation.

Eligibility criteria

Inclusion Criteria:

* male, or female subjects aged 18-85 years;
* diabetes mellitus (type 1 or 2) documented at least 12 months prior to Visit 1;
* presence of a diabetic foot ulcer meeting the following criteria (Index ulcer):

  * grade 1 or 2 according to the Wagner classification;
  * if applicable, surgically debrided ≥ 7 days prior to Visit 1;
  * at the time of randomisation:
* sized 1 - 25 cm2;
* present for ≥ 14 days;
* offloaded for ≥ 7 days;
* not infected.
* HbA1c ≤ 10% (DCCT) or 85.8 mmol/mol (IFCC) at Visit 1;
* willing and able to comply with the scheduled procedures;
* legally capable, able to understand the provided information and willing to sign the informed consent form.

Exclusion Criteria:

* known contraindication for application of hydrogel dressings, incl. Berovenal® and NU-GEL Hydrogel with Alginate;
* at the time of randomisation - documented reduction in Index ulcer area by \> 20%, as compared to its size at Visit 1;
* Index ulcer primarily caused by a medical condition other than diabetes mellitus;
* inadequate arterial circulation to the foot documented within 28 days prior to Visit 1, or during the screening period:

  * Ankle-brachial Index \< 0.7 or \> 1.3 and/or
  * Toe-brachial Index \< 0.7;
* presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1;
* use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to Visit 1, or documented intention to use them during the subject's participation;
* use of any investigational drug(s) or device(s), systemic immunosuppressive treatment (including systemic corticosteroids), or application of topical steroids to the Index ulcer surface, within 28 days prior to Visit 1;
* use of cytotoxic chemotherapy and/or radiotherapy within 6 months prior to Visit 1;
* known history of bone cancer or metastatic disease of the affected limb;
* poor nutritional status;
* presence of an on-going uncontrolled renal, hepatic, cardiovascular or other disease that could pose an additional risk for the participant, or could significantly influence interpretation of the results (as evaluated by the investigator);
* known history of non-compliance and/or presence of any condition(s) seriously compromising the subject's ability to adhere to the procedures required by this Clinical Investigational Plan;
* pregnant or breast-feeding females;
* females of childbearing potential not using an effective method of contraception.

Where this trial is running

Kösching, Eichstatt and 8 other locations

• Klinik Kösching — Kösching, Eichstatt, Germany (Recruiting)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
• Diab Serwis Popenda Spółka Jawna — Chorzów, Poland (Recruiting)
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (Recruiting)
• Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET — Krakow, Poland (Recruiting)
• MIKOMED Sp. z o.o. — Lodz, Poland (Recruiting)
• Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej — Olsztyn, Poland (Recruiting)
• Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna — Poznan, Poland (Recruiting)
• Ginemedica Sp. z o.o. Sp. k. — Wroclaw, Poland (Recruiting)

Study contacts

• Study coordinator: Marianna Forgáčová

Conditions Diabetic Foot Ulcer