Actively 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
Led by VULM s.r.o. · Updated on 2024-09-05
66
Participants Needed
9
Research Sites
132 weeks
Total Duration
On this page
Sponsors
V
VULM s.r.o.
Lead Sponsor
P
Premier Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years
- Diagnosed with type 1 or type 2 diabetes at least 12 months before the first visit
- Have a diabetic foot ulcer graded 1 or 2 by Wagner classification
- Ulcer size between 1 and 25 cm2 present for at least 14 days
- Ulcer must be offloaded for at least 7 days and not infected
- HbA1c level at or below 10% (DCCT) or 85.8 mmol/mol (IFCC) at first visit
- Willing and able to follow study procedures
- Able to understand and sign informed consent
You will not qualify if you...
- Known allergy or contraindication to hydrogel dressings including Berovenal4 or NU-GEL Hydrogel
- Ulcer area decreased by more than 20% before randomization compared to first visit
- Ulcer caused by conditions other than diabetes
- Poor blood circulation to the foot (Ankle-brachial Index < 0.7 or > 1.3; Toe-brachial Index < 0.7)
- Acute Charcot's neuro-arthropathy or osteomyelitis in affected foot within 3 months before first visit
- Use of advanced wound dressings with growth factors or skin substitutes within 14 days before first visit
- Use of investigational drugs, systemic immunosuppressants, or topical steroids on ulcer within 28 days before first visit
- Chemotherapy or radiotherapy within 6 months before first visit
- History of bone cancer or metastatic disease in the affected limb
- Poor nutritional status
- Uncontrolled serious disease that could affect safety or results
- History of non-compliance or conditions affecting ability to follow study
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Klinik Kösching
Kösching, Eichstatt, Germany, 85092
Actively Recruiting
2
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
3
Diab Serwis Popenda Spółka Jawna
Chorzów, Poland, 41-500
Actively Recruiting
4
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
5
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Poland, 31-261
Actively Recruiting
6
MIKOMED Sp. z o.o.
Lodz, Poland, 94-238
Actively Recruiting
7
Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
Olsztyn, Poland, 10-561
Actively Recruiting
8
Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
Poznan, Poland, 60-111
Actively Recruiting
9
Ginemedica Sp. z o.o. Sp. k.
Wroclaw, Poland, 50-414
Actively Recruiting
Research Team
M
Marianna Forgáčová
CONTACT
J
Juraj Keszegh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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