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New gel could speed healing of chronic wounds

NCT ID NCT07406152

Disease control Sponsor: i+Med S.Coop. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a gel called ZKARE® for treating chronic ulcers that won't heal on their own. About 134 people with pressure sores, diabetic foot ulcers, or leg ulcers will either get the gel plus standard care, or standard care alone. The goal is to see if the gel helps wounds heal better and faster, and if it's safe to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZKARE® gel (a topical polymeric gel dressing)
What this could lead to
If successful, this gel could become a new option to help heal stubborn chronic ulcers faster and more effectively.
What could go wrong
This is an early-stage trial with only 134 participants, so results may not apply to everyone. The gel is a device, not a drug, so its effect may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic ulcer of skin decubitus ulcer ulcer of lower limbs

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic ulcers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Araba University Hospital

    RECRUITING

    Vitoria-Gasteiz, Álava, Spain

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