ZKARE® gel with ZKAPI® applicator for treating 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 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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: i+Med S.Coop. (Industry-sponsored)
• Locations: 1 site (Vitoria-Gasteiz, Álava)
• Trial ID: NCT07406152 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Vitoria-Gasteiz, Álava

• Araba University Hospital — Vitoria-Gasteiz, Álava, Spain (Recruiting)

Study contacts

• Study coordinator: Josune Torrecilla

Conditions Chronic Ulcers; Pressure ulcers; Hyaluronic acid; Wound healing; Topical gel; venous leg ulcers