Diabetic Foot Ulcer
Conditions
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
Interventions
DEVICEBerovenal®
Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
DEVICENU-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.
Sponsors
Premier Research
VULM s.r.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area. | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical efficacy based on median time until complete Index ulcer closure | 8 weeks | — |
| 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 clinical efficacy based on mean percentage change of the Index ulcer area | 2, 4, 6 and 8 weeks | — |
| Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers | 8 weeks | — |
| Evaluation of safety based on proportion of target wounds with a documented wound infection | 8 weeks | — |
| Evaluation of safety occurrence of adverse events, device failures or complaints | 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 improvement in the subject's reported quality of life assessed by the Wound-QoL | 2, 4, 6 and 8 weeks | — |
Countries
Germany, Poland
Contacts
Primary ContactMarianna Forgáčová
Backup ContactJuraj Keszegh
Outcome results
None listed