Diabetic Foot UlcerNCT06584617
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
A study testing Berovenal® and NU-GEL Hydrogel with Alginate in people with Diabetic Foot Ulcer, run by VULM s.r.o. at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Berovenal® and NU-GEL Hydrogel with Alginate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 17 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Poland7 sites, 7 recruiting
- Recruiting
Diab Serwis Popenda Spółka Jawna
Chorzów, 41-500
Karolina Porodzik, +48 515322854, 'karolina.pordzik@farmepo.com'
Grażyna Popenda
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Anna Korzon-Burakowska, + 48609091454, anna.korzon-burakowska@gumed.edu.pl
Anna Korzon-Burakowska
- Recruiting
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, 31-261
Marzena Skiba, +48 517459770, mskiba@diab-endo-met.pl
Joanna Mirocka
- Recruiting
MIKOMED Sp. z o.o.
Lodz, 94-238
Jacek Mikosinski, +48602226897, mikomed@mikomed.pl
Jacek Mikosinski
- Recruiting
Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej
Olsztyn, 10-561
Robert Modzelewski, +48 667517993, robur23@interia.eu
Robert Modzelewski
- Recruiting
Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna
Poznan, 60-111
Marcelina Kocińska, +48 518345945, marcelina.kocinska@farmepo.com
Jarosław Opiela
- Recruiting
Ginemedica Sp. z o.o. Sp. k.
Wroclaw, 50-414
Jolanta Cholewa, +48 881334481, j.cholewa@ginemedica.pl
Michal Torz
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Ilka Buss, +49 6221 56-37920, Ilka.buss@med.uni-heidelberg.de
Christian Erbel
- Recruiting
Klinik Kösching
Kösching, Eichstatt, 85092
Alexander Hansen, +49 845671-431, Alexander.Hansen@klinikallianz.com
Alexander Hansen
About this study
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
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:
Read more
- 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
- Being tested
- Berovenal®, NU-GEL Hydrogel with Alginate
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
NU-GEL Hydrogel with AlginateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Berovenal® | Experimental | Not described Receives: Device: Berovenal® |
| NU-GEL Hydrogel with Alginate | Active comparator | Not described Receives: Device: NU-GEL Hydrogel with Alginate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
Measured: 8 weeks
Secondary outcomes (8)
Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers
Measured: 8 weeks
Evaluation of clinical efficacy based on median time until complete Index ulcer closure
Measured: 8 weeks
Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80%
Measured: 4, 6 and 8 weeks
Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area
Measured: 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
Measured: 2, 4, 6 and 8 weeks
Evaluation of safety based on proportion of target wounds with a documented wound infection
Measured: 8 weeks
Evaluation of safety occurrence of adverse events, device failures or complaints
Measured: 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.
Measured: 2, 4, 6 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start17 May 2023
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VULM s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584617
- Sponsor's protocol ID
- BER202001
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06584617
- Acronym / sponsor ID
- BER202001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- VULM s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 17 May 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berovenal® | Experimental | Device: Berovenal® |
| NU-GEL Hydrogel with Alginate | Active comparator | Device: NU-GEL Hydrogel with Alginate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- sized 1 - 25 cm2;
- present for ≥ 14 days;
Key exclusion criteria (16 listed)
- 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:
- presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berovenal®Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap. | Device | Berovenal® |
| NU-GEL Hydrogel with AlginateTransparent, 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. | Device | NU-GEL Hydrogel with Alginate |
Primary outcome
Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
Time frame: 8 weeks
8 secondary outcomes
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
Time frame: 2, 4, 6 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berovenal® and NU-GEL Hydrogel with Alginate in people with Diabetic Foot Ulcer, run by VULM s.r.o. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianna Forgáčová (+421 918 415 585, regulatory@vulm.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.