Actively Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Led by i+Med S.Coop. · Updated on 2026-02-19
134
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
I
i+Med S.Coop.
Lead Sponsor
B
Bioaraba Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older)
- Presence of at least one chronic hard-to-heal ulcer including 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 2 0.7-0.89; mild PAD)
- Mixed-etiology venous ulcers or 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
- Ability to understand and sign informed consent before any protocol procedures
You will not qualify if you...
- Ulcers of etiologies not listed in inclusion criteria
- Ischaemic, neoplastic, or atypical ulcers
- Severe comorbidities compromising safety or study compliance, including severe malnutrition, palliative or terminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III/IV or dialysis
- Ulcers with moderate to severe infection per PEDIS-IDSA grading scale
- Known allergy or sensitivity to any component of the investigational product
- Any condition that in the investigator's opinion may compromise safety or adherence
- Pregnancy or planned breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Araba University Hospital
Vitoria-Gasteiz, Álava, Spain
Actively Recruiting
Research Team
J
Josune Torrecilla
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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