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New wound dressing put to the test against diabetic foot ulcers

NCT ID NCT06667752

Symptom relief Sponsor: Nanordica Medical OU Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing a new antibacterial wound dressing to see if it helps heal diabetic foot ulcers better than a standard silver dressing. The trial enrolls adults with diabetic foot ulcers that have lasted more than four weeks. Participants are randomly assigned to receive either the new dressing or the standard dressing for four weeks, followed by eight weeks of standard care. The main goal is to measure wound healing at 12 weeks.

What this could mean

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

Active substance
an advanced antibacterial wound dressing
What this could lead to
If it works, this could offer a new option for treating diabetic foot ulcers, which are a common and serious complication of diabetes.
What could go wrong
The trial is mid-stage and may not show a clear advantage over the standard dressing. Wound healing is complex, and results in a controlled study may not reflect real-world outcomes.

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 136 people

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

Started

Oct 2024

Expected to finish

Dec 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: * Voluntary, written informed consent obtained prior to any study related activities. * Males and females aged ≥18 years. * DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm. * IWGDF/IDSA Wound infection grades 1 (absent) or 2. * Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures. * Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg. Exclusion Criteria: * Ssystemic or topical antibiotic therapy within 7 days before the enrolment. * Any wound with known associated osteomyelitis or positive probe-to-bone test. * Previous randomization in this clinical trial. * Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study. * Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks. * Patients suffering cardiac disorders grade NYHA IV. * Patients suffering hepatic disorders grade Child-Pugh C. * Stage 4 cancer. * Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Diabetic foot infection Diabetic foot ulcer

Contacts and locations

Locations

  • Centro de Salud San Benito

    Jerez de la Frontera, Cádiz, Spain

  • Centro de Salud de Arcos de la Frontera

    Arcos de la Frontera, Cádiz, Spain

  • Clínica Universitaria de Podología de la Universidad Complutense de Madrid

    Madrid, Madrid, Spain

  • East Tallinn Central Hospital

    Tallinn, Harju, Estonia

  • Hospital Puerta del Mar

    Cadiz, Cádiz, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Fundación Alcorcón

    Madrid, Spain

  • Hospital Universitario de Donostia

    San Sebastián, Spain

  • Hospital de León

    León, León, Spain

  • North Estonia Medical Centre Foundation

    Tallinn, Harju, Estonia

  • Tartu University Hospital

    Tartu, Tartu, Estonia

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