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

NCT06584617 | Recruiting

• 1 other identifier: BER202001
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 9

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

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.

  8 weeks

Secondary Outcomes (8)

• Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers

  8 weeks

• 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 improvement in the subject's reported quality of life assessed by the Wound-QoL

  2, 4, 6 and 8 weeks

Study Arms (2)

Berovenal®

EXPERIMENTAL

Device: Berovenal®

NU-GEL Hydrogel with Alginate

ACTIVE COMPARATOR

Device: NU-GEL Hydrogel with Alginate

Interventions

Berovenal® DEVICE

Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.

Berovenal®

NU-GEL Hydrogel with Alginate DEVICE

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.

NU-GEL Hydrogel with Alginate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• VULM s.r.o.: lead
• Premier Research: collaborator

Study Sites (9)

Klinik Kösching

Kösching, Eichstatt, 85092, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Diab Serwis Popenda Spółka Jawna

Chorzów, 41-500, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, 31-261, Poland

RECRUITING

MIKOMED Sp. z o.o.

Lodz, 94-238, Poland

RECRUITING

Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej

Olsztyn, 10-561, Poland

RECRUITING

Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna

Poznan, 60-111, Poland

RECRUITING

Ginemedica Sp. z o.o. Sp. k.

Wroclaw, 50-414, Poland

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Marianna Forgáčová

CONTACT

+421 918 415 585; regulatory@vulm.sk

Juraj Keszegh

CONTACT

+421 904 967 555; juraj.keszegh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 5, 2024
• Study Start: May 17, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

DE (2); PL (7)