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
NCT ID: NCT06584617
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-05-17
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Berovenal®
Berovenal®
Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
NU-GEL Hydrogel with Alginate
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.
Interventions
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Berovenal®
Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Premier Research
OTHER
VULM s.r.o.
INDUSTRY
Responsible Party
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Locations
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Klinik Kösching
Kösching, Eichstatt, Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Diab Serwis Popenda Spółka Jawna
Chorzów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, , Poland
MIKOMED Sp. z o.o.
Lodz, , Poland
Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
Olsztyn, , Poland
Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
Poznan, , Poland
Ginemedica Sp. z o.o. Sp. k.
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Alexander Hansen
Role: backup
Christian Erbel
Role: backup
Grażyna Popenda
Role: backup
Anna Korzon-Burakowska
Role: backup
Joanna Mirocka
Role: backup
Jacek Mikosinski
Role: backup
Robert Modzelewski
Role: backup
Jarosław Opiela
Role: backup
Michal Torz
Role: backup
Other Identifiers
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BER202001
Identifier Type: -
Identifier Source: org_study_id
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