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
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: Berovenal®Device: NU-GEL Hydrogel with Alginate
- Registration Number
- NCT06584617
- Lead Sponsor
- VULM s.r.o.
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Berovenal® Berovenal® - NU-GEL Hydrogel with Alginate NU-GEL Hydrogel with Alginate -
- Primary Outcome Measures
Name Time Method Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area. 8 weeks
- Secondary Outcome Measures
Name Time Method Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers 8 weeks Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL 2, 4, 6 and 8 weeks Evaluation of safety based on proportion of target wounds with a documented wound infection 8 weeks Evaluation of clinical efficacy based on median time until complete Index ulcer closure 8 weeks Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area 2, 4, 6 and 8 weeks Evaluation of clinical efficacy based on wound healing process 2, 4, 6 and 8 weeks The analysis will inolve evaluation wound depth, presence of granulation tissue, exsudate and infection at individual time points.
Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80% 4, 6 and 8 weeks Evaluation of safety occurrence of adverse events, device failures or complaints 8 weeks
Trial Locations
- Locations (9)
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
🇵🇱Kraków, Poland
Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
🇵🇱Olsztyn, Poland
Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
🇵🇱Poznań, Poland
Ginemedica Sp. z o.o. Sp. k.
🇵🇱Wrocław, Poland
MIKOMED Sp. z o.o.
🇵🇱Łódź, Poland