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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
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.
Klinik Kösching
Kösching, Eichstatt, Germany
RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGDiab Serwis Popenda Spółka Jawna
Chorzów, Poland
RECRUITINGUniwersyteckie Centrum Kliniczne
Gdansk, Poland
RECRUITINGMedyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Poland
RECRUITINGMIKOMED Sp. z o.o.
Lodz, Poland
RECRUITINGWojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
Olsztyn, Poland
RECRUITINGCentrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
Poznan, Poland
RECRUITINGGinemedica Sp. z o.o. Sp. k.
Wroclaw, Poland
RECRUITINGEvaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
Time frame: 8 weeks
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
The analysis will inolve evaluation wound depth, presence of granulation tissue, exsudate and infection at individual time points.
Time frame: 2, 4, 6 and 8 weeks
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