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Tests treatment safety and results for Diabetic Foot Ulcer
Official title 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
ClinicalTrials.gov ID: NCT06584617
What this study is testing
- What it's testing
- 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®.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- male, or female people 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;
You likely can't join 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 \ 1.3 and/or
- Toe-brachial Index \< 0.7;
See the full eligibility criteria
- male, or female people 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.
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kösching, Eichstatt, Germany
- Heidelberg, Germany
- Chorzów, Poland
- Gdansk, Poland
- Krakow, Poland
- Lodz, Poland
- Olsztyn, Poland
- Poznan, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kösching, Eichstatt, Germany; Heidelberg, Germany; Chorzów, Poland; Gdansk, Poland; Krakow, Poland; Lodz, Poland and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.