Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.
i+Med S.Coop.
134 participants
Nov 14, 2025
INTERVENTIONAL
Conditions
Summary
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. Participants are randomized to receive either ZKARE® in addition to standard wound care or standard care alone. The primary efficacy endpoint is the change in wound condition assessed through the RESVECH 2.0 scale, recorded at baseline and throughout treatment and follow-up visits. The primary safety endpoint is the incidence of serious adverse events (SAEs). Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, quality-of-life measures (DLQI), patient satisfaction, investigator global assessment, cost-effectiveness, and product usability. The study aims to generate evidence on the performance, safety, and clinical usefulness of ZKARE® for chronic wound management.
Eligibility
Inclusion Criteria11
- 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, I, II, III / Stage B; class C6/C6r venous leg ulcers measured with CEAP scale ; neuro-ischaemic ulcers with adequate distal perfusion (ABI/ITB ≥ 0.7-0.89; mild PAD); mixed-etiology venous ulcers and any chronic lower-limb lesion with palpable distal pulses.
- 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.
- 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 dialysis.
- 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.
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Interventions
ZKARE® is applied topically after routine wound cleansing and debridement. Using the sterile ZKAPI® applicator, the gel is distributed to fully cover the wound bed, including irregular or cavitated areas. The treated wound is then covered with the appropriate secondary dressing following standard clinical practice. The application is repeated at each treatment session until complete closure or the end of the 12-week follow-up period. All sessions include RESVECH 2.0 scoring, standardized photographs, and safety assessments
Standard care includes wound cleansing, debridement when required, and selection of secondary dressings according to wound characteristics such as exudate level, infection status, depth, and perilesional skin condition. No investigational gel is applied. At each treatment visit and follow-up time point, standardized wound photographs, RESVECH 2.0 scoring, closure metrics, and safety assessments are recorded according to the same schedule as the investigational arm.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07406152