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Tests treatment safety and results for Chronic Ulcers
Official title Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
ClinicalTrials.gov ID: NCT07406152
What this study is testing
- What it's testing
- This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. The study includes 134 ulcers of different etiologies-pressure ulcers, neuropathic diabetic foot ulcers, and venous leg ulcers-meeting predefined selection criteria.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years).
- Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic...
- Ulcer size between 1 cm² and 100 cm².
- Ability and willingness to comply with all study visits and procedures according to the clinical protocol.
- Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.
You likely can't join if
- Ulcers of etiologies not listed in the inclusion criteria.
- Ischaemic, neoplastic or atypical ulcers.
- Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative/terminal status, severe anemia...
- Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.
- Known allergy or sensitivity to any component of the investigational product.
- Any condition that, in the investigator's opinion, may compromise patient safety or adherence to the protocol.
See the full eligibility criteria
- Adult patients (≥18 years).
- Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic diabetic foot ulcers (grade I, II or III), Wagner Grade I-III or Texas 0...
- Ulcer size between 1 cm² and 100 cm².
- Ability and willingness to comply with all study visits and procedures according to the clinical protocol.
- Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.
- Ulcers of etiologies not listed in the inclusion criteria.
- Ischaemic, neoplastic or atypical ulcers.
- Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative/terminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III/IV or in...
- Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.
- Known allergy or sensitivity to any component of the investigational product.
- Any condition that, in the investigator's opinion, may compromise patient safety or adherence to the protocol.
- Pregnancy or planned breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Vitoria-Gasteiz, Álava, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vitoria-Gasteiz, Álava, Spain. 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.