Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.

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.

NCT Number	NCT07406152
Lead Sponsor	i+Med S.Coop. Collaborators: Bioaraba Health Research Institute
Conditions	Chronic Ulcers
Enrollment	134 participants
Start Date	2025-11-14
Primary Completion	2026-06 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2026-02-19