Clinical trial NCT06584617: 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
Official title: A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: VULM s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2024-09-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers
timeFrame: 8 weeks
measure: Evaluation of clinical efficacy based on median time until complete Index ulcer closure
timeFrame: 8 weeks
measure: Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80%
timeFrame: 4, 6 and 8 weeks
measure: Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area
timeFrame: 2, 4, 6 and 8 weeks
measure: Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL
timeFrame: 2, 4, 6 and 8 weeks
measure: Evaluation of safety based on proportion of target wounds with a documented wound infection
timeFrame: 8 weeks
measure: Evaluation of safety occurrence of adverse events, device failures or complaints
timeFrame: 8 weeks
measure: Evaluation of clinical efficacy based on wound healing process
timeFrame: 2, 4, 6 and 8 weeks
Other outcomes:
Locations:
city: Kösching
country: Germany
facility: Klinik Kösching
state: Eichstatt
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Chorzów
country: Poland
facility: Diab Serwis Popenda Spółka Jawna
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
city: Olsztyn
country: Poland
facility: Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
city: Poznań
country: Poland
facility: Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
city: Wrocław
country: Poland
facility: Ginemedica Sp. z o.o. Sp. k.
city: Łódź
country: Poland
facility: MIKOMED Sp. z o.o.
Study officials:
References: