ZKARE® gel with ZKAPI® applicator for treating chronic ulcers
Official title: Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.
Run by i+Med S.Coop. · NCT07406152 · Data updated 2026-11-12
This trial will try adding ZKARE® gel applied with the ZKAPI® applicator to standard wound care to see if it helps heal chronic pressure, diabetic foot, and venous leg ulcers faster and safer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | i+Med S.Coop. Industry-sponsored |
| Locations | 1 site (Vitoria-Gasteiz, Álava) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | March 2027 |
| Study ends | August 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07406152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with at least one chronic hard-to-heal ulcer—pressure ulcers (Grade II–IV), neuropathic diabetic foot ulcers (Wagner/Texas grades listed), or CEAP C6/C6r venous leg ulcers—measuring 1–100 cm² and able to consent and attend study visits are eligible.
✕Probably not a fit
Patients with ischemic, neoplastic, atypical ulcers, severe comorbidities that compromise safety or compliance, or ulcers outside the 1–100 cm² range are unlikely to benefit from this intervention in the trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-blind controlled comparison of ZKARE® topical polymeric gel plus its ZKAPI® applicator versus standard wound care alone in 134 chronic hard-to-heal ulcers of mixed etiologies. Ulcers are randomized (patients may contribute more than one independent lesion), with treatment sessions following routine practice and blinded assessment using measures to prevent direct wound visualization. The primary efficacy outcome is change in the RESVECH 2.0 wound score over baseline with a ≥2-point improvement at Week 4 considered clinically relevant, and the primary safety outcome is incidence of serious adverse events. Secondary outcomes include wound closure metrics, time to full closure, quality-of-life (DLQI), patient satisfaction, investigator global assessment, and cost-effectiveness, with follow-up visits around 2, 4, 8, and 12 weeks.
Why it matters
Potential benefit: If successful, ZKARE® plus the ZKAPI® applicator could speed wound healing and increase complete closure rates for chronic hard-to-heal ulcers, potentially reducing complications and care burden.
How similar studies have gone: Similar topical hydrogels and moisture-managing dressings have shown benefit in some trials for wound healing, though results vary and high-quality randomized data for this specific polymeric gel and applicator combination are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Araba University Hospital
Vitoria-Gasteiz, Álava, Spain Recruiting
Study contacts
- Study coordinator: Josune Torrecilla
- Email: jtorrecilla@imasmed.com
- Phone: +34945561134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.