The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing

Official title

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

Overview

The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®. The main questions it aims to answer are: * Does medical device Berovenal® lower the size of diabetic foot ulcer? * What medical problems do participants have when using medical device Berovenal®? Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use). Participants will: * Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device

Interventions

• Device Berovenal®
  Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
• Device NU-GEL Hydrogel with Alginate
  Transparent, easy to spread and water-washable hydrogel in ampoule (concertina pack) containing 25 g or 15 g of hydrogel and closed with a plastic cap.

Primary outcome measures

• Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area. [Time frame: 8 weeks]

Secondary outcome measures (8)

• Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers [Time frame: 8 weeks]
• Evaluation of clinical efficacy based on median time until complete Index ulcer closure [Time frame: 8 weeks]
• Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80% [Time frame: 4, 6 and 8 weeks]
• Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area [Time frame: 2, 4, 6 and 8 weeks]
• Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL [Time frame: 2, 4, 6 and 8 weeks]
• Evaluation of safety based on proportion of target wounds with a documented wound infection [Time frame: 8 weeks]
• Evaluation of safety occurrence of adverse events, device failures or complaints [Time frame: 8 weeks]
• Evaluation of clinical efficacy based on wound healing process [Time frame: 2, 4, 6 and 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 7 centers

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

Germany · 2 centers

• Klinik Kösching — Kösching
• Universitätsklinikum Heidelberg — Heidelberg

Identifiers

NCT: NCT06584617 · BER202001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗