Status:
RECRUITING
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
Lead Sponsor:
VULM s.r.o.
Collaborating Sponsors:
Premier Research
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 fe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06584617
Start Date
May 17 2023
End Date
December 1 2025
Last Update
September 5 2024
Active Locations (9)
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1
Klinik Kösching
Kösching, Eichstatt, Germany, 85092
2
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
3
Diab Serwis Popenda Spółka Jawna
Chorzów, Poland, 41-500
4
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214