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

ConditionChronic Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsori+Med S.Coop.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZKARE®

    Device

    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

    Procedure/Surgery

    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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: ZKARE®Experimental treatment 1 intervention
Group B: Standard Wound CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Incidence of Serious Adverse Events (SAEs)

Incidence, frequency, and nature of serious adverse events during the study.

Time frame
12 weeks

Secondary outcomes

1

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
2

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
3

Total Wound Closure (%)

Percentage of wounds achieving complete epithelialization.

Time frame
12 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

i+Med S.Coop.

Lead sponsor

Bioaraba Health Research Institute

Collaborator

Source ClinicalTrials.gov
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