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Major study aims to uncover why diabetic foot ulcers lead to early death

NCT ID NCT04533152

Knowledge-focused Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 1,000 adults with diabetic foot ulcers for up to 5 years to learn why some have worse outcomes, including death. Researchers will track health events and build a risk score to identify those most at risk. The goal is to better understand the disease and improve future care.

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.

Participants

About 1,000 people

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

Started

Nov 2021

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

PDF study is designed to be the first French multicentre, observational and prospective cohort of patients with DFU referred from the community into secondary and tertiary care foot clinics. Twenty-three French centres agreed to participate in this study. Each centre will recruit during the 3-year inclusion period.

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: Adults with diabetes and DFU, defined as a foot skin ulceration or open LLA wound, measuring at least 5 mm of diameter, located below the malleolus, and induced by diabetic complications. In the case of an amputation before inclusion, the amputation stump will be considered as the main wound and not the wound that led to the amputation. Exclusion Criteria: * Acute or chronic lower-limb ischemia without open skin wound, * Foot infection without open skin wound, * Intercurrent disease prohibiting participation in an observational study, * Pregnancy or breastfeeding * Curatorship or guardianship * Prisoners -- Patient currently participating to more than one other clinical study (interventional or observational, 2 study maximum including PDF) or currently participating to another study interfering with standard care of diabetic foot

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot injury

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

    25 sites. 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

  • AP - HM - Hôpital de la Conception

    RECRUITING

    Marseille, France

  • AP-HP - Hôpital Bichat

    RECRUITING

    Paris, France

  • AP-HP - Hôpital Lariboisière

    RECRUITING

    Paris, France

  • AP-HP - Hôpital Pitié-Salpétrière

    RECRUITING

    Paris, France

  • CH Pierre Bérégovoy

    RECRUITING

    Nevers, France

  • CH Sud Francilien

    RECRUITING

    Corbeil-Essonnes, France

  • CHRU de Lille - Hôpital Claude Huriez

    RECRUITING

    Lille, France

  • CHU Côte de Nacre

    RECRUITING

    Caen, France

  • CHU Nîmes - Hôpital universitaire Carémeau

    NOT_YET_RECRUITING

    Nîmes, France

  • CHU de Bocage Sud

    RECRUITING

    Dijon, France

  • CHU de La Réunion - Site Sud

    RECRUITING

    La Réunion, France

  • CHU de Montpellier - Hôpital Lapeyronie

    RECRUITING

    Montpellier, France

  • CHU de Nantes Hôpital Nord Laennec

    RECRUITING

    Nantes, France

  • CHU de Nice - Hôpital l'Archet 2

    RECRUITING

    Nice, France

  • CHU de Rouen

    RECRUITING

    Rouen, France

  • CHU de Toulouse - Hôpital Rangueil

    RECRUITING

    Toulouse, France

  • CHU de la Martinique

    WITHDRAWN

    Fort-de-France, Martinique

  • CHU de la Milétrie

    RECRUITING

    Poitiers, 86021, France

  • Centre Hospitalier Saint Benoit

    RECRUITING

    Saint-Benoît, 97470, France

  • Groupe Hospitalier de La Rochelle Ré Aunis

    RECRUITING

    La Rochelle, France

  • HCL - Hôpital Lyon sud

    RECRUITING

    Pierre-Bénite, France

  • Hopital Haut-Leveque

    RECRUITING

    Pessac, 33600, France

  • Hôpital Paris Saint Joseph

    RECRUITING

    Paris, France

  • Hôpital d'Instruction des Armées Bégin

    RECRUITING

    Saint-Mandé, France

  • Hôtel Dieu

    NOT_YET_RECRUITING

    Le Creusot, France

  • Maison de Santé Protestante Bagatelle - Hôpital Bagatelle

    RECRUITING

    Talence, 33404, France

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