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

Condition(s) studied

Investigational drug(s) / intervention(s)

ZKARE®: 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 Wound Care: 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.

Study 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

Primary outcome measure(s)

• RESVECH Scale 2.0 — 12 weeks or wound healing
  Change in the RESVECH 2.0 wound assessment scale, which evaluates wound size, depth, granulation tissue quality, exudate amount/type, clinical signs of infection/inflammation, and perilesional skin condition. Measured at baseline and at each treatment and follow-up visit until complete closure or at week 12. A ≥2-point improvement at week 4 is considered clinically relevant.
• Incidence of Serious Adverse Events (SAEs) — 12 weeks
  Incidence, frequency, and nature of serious adverse events during the study.

Trial sites (1)

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