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

VULM s.r.o.

Status

Enrolling

Conditions

Diabetic Foot Ulcer

Study type

Interventional

Funder types

Industry

Identifiers

NCT06584617

BER202001

Details and patient eligibility

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

Enrollment

66 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.