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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Ulcers
• Intervention / Treatment: Device: ZKARE®; Procedure: Standard Wound Care

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josune Torrecilla; Phone Number: +34945561134; Email: jtorrecilla@imasmed.com

Study Locations

• Spain
  • Álava
    • Vitoria-Gasteiz, Álava, Spain
      • Recruiting
      • Araba University Hospital
      • Contact: Garbiñe Ruiz de Gordoa; Phone Number: +34 945 00 70 00; Email: garbiñe.ruizdegordoacampo@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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, 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.

Exclusion Criteria:

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZKARE®; 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®; 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
Active Comparator: Standard Wound Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks or wound healing
Incidence of Serious Adverse Events (SAEs)	Incidence, frequency, and nature of serious adverse events during the study.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%).	12 weeks
Total Wound Closure (%)	Percentage of wounds achieving complete epithelialization.	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.	12 weeks
Cost-Effectiveness Analysis (Healthcare Resources Used)	Quantification of materials, products, consumables, and healthcare professional time in each treatment session. Reported as €/patient.	12 weeks
Dermatology Life Quality Index (DLQI) Score	Change in DLQI score (0-30), with higher scores indicating worse dermatology-related quality of life.	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.	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.	12 weeks
Incidence of Non-Serious Adverse Events (AEs)	Recording of the incidence and nature of all non-serious adverse events.	12 weeks

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Bioaraba Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Wound healing; Hyaluronic acid; venous leg ulcers; Pressure ulcers; Topical gel
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: ZKARE-PIC01-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No