An interventional study of ZKARE® and Standard Wound Care in Chronic Ulcers, sponsored by i+Med S.Coop.. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by i+Med S.Coop. · Not applicable, Interventional, and Treatment
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.
Chronic ulcers such as pressure ulcers, neuropathic diabetic foot ulcers and venous leg ulcers frequently fail to follow normal healing phases and require comprehensive management. Many existing dressings act through a single mechanism and are limited in effectiveness for complex or exudative wounds. ZKARE® is a sterile, biocompatible polymeric gel intended for topical use that provides a moist microenvironment, absorbs excess exudate and contributes to bacterial control. The product is applied using ZKAPI®, a sterile Luer-Lock applicator designed to improve precision and ease of administration.
This prospective, randomized, single-blind, controlled clinical investigation compares ZKARE® plus standard care with standard care alone in 134 chronic ulcers of different etiologies. Patients may contribute more than one ulcer if lesions are independent. After informed consent, ulcers are randomized, and treatment sessions follow routine clinical practice, with ZKARE® added only in the investigational arm. Blinding is maintained by preventing direct visualization of the wound and through iso-appearance of materials. Follow-up visits occur at approximately 2, 4, 8 and 12 weeks.
The primary efficacy endpoint is the change in RESVECH 2.0 score, recorded at baseline, each treatment session and all follow-up visits; a ≥2-point improvement at Week 4 is considered clinically relevant. The primary safety endpoint is the incidence of serious adverse events. Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, DLQI, patient satisfaction, investigator global assessment, usability and cost-effectiveness, as well as non-serious adverse events.
Group comparisons use appropriate statistical tests for categorical and continuous variables, repeated-measures analyses and ANCOVA where applicable, under an intention-to-treat approach. The sample size of 134 ulcers gives 80% power to detect expected differences in RESVECH 2.0 change. The study aims to evaluate the clinical performance and safety of ZKARE® and ZKAPI® in the treatment of chronic hard-to-heal ulcers
Exclusion Criteria:
Participants assigned to this arm receive standard wound care plus topical application of the investigational gel ZKARE®, applied using the ZKAPI® applicator during each wound-care session.
Device: ZKARE®
Participants assigned to this arm receive standard wound management according to routine clinical practice, without the use of the investigational product.
Procedure: Standard Wound Care
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.
RESVECH Scale 2.0
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.
Time frame: 12 weeks or wound healing
Incidence of Serious Adverse Events (SAEs)
Incidence, frequency, and nature of serious adverse events during the study.
Time frame: 12 weeks
Wound Closure Rate (mm²/day)
Rate of epithelialization based on the area healed divided by the time since treatment initiation. Assessed at each treatment and follow-up visit.
Time frame: 12 weeks
Percentage of Wound Closure (%)
Percentage reduction of the initial wound area at each assessment. A ≥30% reduction by week 4 is considered clinically relevant. Kaplan-Meier curves may be used to evaluate closure thresholds (≥30%-90%).
Time frame: 12 weeks
Total Wound Closure (%)
Percentage of wounds achieving complete epithelialization.
Time frame: 12 weeks
Estimated Time to Full Closure (days)
For wounds not completely healed by week 12, linear regression based on closure rate is used to estimate time to complete healing.
Time frame: 12 weeks
Cost-Effectiveness Analysis (Healthcare Resources Used)
Quantification of materials, products, consumables, and healthcare professional time in each treatment session. Reported as €/patient.
Time frame: 12 weeks
Dermatology Life Quality Index (DLQI) Score
Change in DLQI score (0-30), with higher scores indicating worse dermatology-related quality of life.
Time frame: 12 weeks
Patient Satisfaction (Likert Scale)
Patient satisfaction rated at study end (Very dissatisfied, dissatisfied, neutral, satisfied and very satisfied). Outcome to be reported as the percentage of "Satisfied" + "Very satisfied" answers.
Time frame: 12 weeks
Investigator Global Assessment (IGA)
Clinical impression of overall wound evolution (Worsening / No improvement / Mild improvement / Significant improvement). Outcome to be reported as the percentage of mild or significant improvement achievement.
Time frame: 12 weeks
Incidence of Non-Serious Adverse Events (AEs)
Recording of the incidence and nature of all non-serious adverse events.
Time frame: 12 weeks
Plan to share: No
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