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Can a Tailor-Made felt dressing speed up diabetic wound healing?

NCT ID NCT04058639

Disease control Sponsor: Helse Møre og Romsdal HF 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether custom-cut felt dressings can reduce the healing time for diabetic foot ulcers compared to standard felt relief. Adults with type 1 or 2 diabetes and neuropathic foot wounds will receive either custom felt, shaped to fit their wound, or a standard U-shaped felt, changed weekly. The goal is to see if the personalized approach leads to faster wound closure.

What this could mean

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

Active substance
custom felt relief (a procedure where felt is cut and layered to fit each wound, changed weekly)
What this could lead to
If custom felt relief works, it could shorten the time people with diabetic foot ulcers need treatment, potentially reducing discomfort and healthcare costs.
What could go wrong
This is a small trial, and the outcome depends on how well the custom felt fits and stays in place. Results may not apply to all patients, and there is a risk of skin irritation or infection.

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 74 people

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

Started

Oct 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

45 to 80 years

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: * diagnosed with Diabetes Mellitus Type 1 or 2 * has neuropathic wounds under the foot * understands and speaks Norwegian well * competent to give consent Exclusion Criteria: * responds to the filament glue and/or the tape used in treatment * in need of vascular surgery intervention * to be admitted to the hospital * in need of intravenously administered antibiotics due to wound infection.

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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 ulcer

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

  • Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF

    RECRUITING

    Molde, Norway

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