Diabetic Foot UlcerPDFNCT04533152
Prognostic Determinants in Patients With Diabetic Foot Ulcer.
An observational study of Diabetic Foot Ulcer, run by University Hospital, Bordeaux at 26 sites in 2 countries.
Trial summary
The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 1,000 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 24 Nov 2021to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Vincent RIGALLEAU, Pr contact
26 sites in 2 countries
France25 sites, 25 recruiting
- Recruiting
CHU Côte de Nacre
Caen
Yves REZNIK, Pr, reznik-y@chu-caen.fr
- Recruiting
CH Sud Francilien
Corbeil-Essonnes
Dured DARDARI, Dr, dured.dardari@chsf.fr
- Recruiting
CHU de Bocage Sud
Dijon
Benjamin BOUILLET, Dr, benjamin.bouillet@chu-dijon.fr
- Recruiting
CHU de La Réunion - Site Sud
La Réunion
Estelle NOBECOURT, Dr, estelle.nobecourt@chu-reunion.fr
- Recruiting
Groupe Hospitalier de La Rochelle Ré Aunis
La Rochelle
Frederique DUENGLER, Dr, frederique.duengler@ght-atlantique17.fr
- Not yet recruiting
Hôtel Dieu
Le Creusot
Sylvaine CLAVEL, Dr, clavel.sylvaine@wanadoo.fr
- Recruiting
CHRU de Lille - Hôpital Claude Huriez
Lille
Florence BAUDOUX, Dr, florence.baudoux@chru-lille.fr
- Recruiting
AP - HM - Hôpital de la Conception
Marseille
René VALERO, Pr, Rene.VALERO@ap-hm.fr
- Recruiting
CHU de Montpellier - Hôpital Lapeyronie
Montpellier
Ariane SULTAN, Pr, a-sultan@chu-montpellier.fr
- Recruiting
CHU de Nantes Hôpital Nord Laennec
Nantes
Samy HADJADJ, Pr, samy.hadjadj@univ-nantes.fr
- Recruiting
CH Pierre Bérégovoy
Nevers
Ardina DESPLAN, Dr, ardina.desplan@ch-nevers.fr
- Recruiting
CHU de Nice - Hôpital l'Archet 2
Nice
Nicolas CHEVALIER, Dr, chevalier.n@chu-nice.fr
- Not yet recruiting
CHU Nîmes - Hôpital universitaire Carémeau
Nîmes
Sophie SCHULDINER, Dr, sophie.schuldiner@chu-nimes.fr
- Recruiting
AP-HP - Hôpital Bichat
Paris
Louis POTIER, Pr, louis.potier@aphp.fr
- Recruiting
AP-HP - Hôpital Lariboisière
Paris
Jean-François GAUTIER, Pr, jean-francois.gautier@aphp.fr
- Recruiting
AP-HP - Hôpital Pitié-Salpétrière
Paris
Olivier BOURRON, Pr, olivier.bourron@aphp.fr
- Recruiting
Hôpital Paris Saint Joseph
Paris
Olivier DUPUY, Dr, odupuy@hpsj.fr
- Recruiting
Hopital Haut-Leveque
Pessac, 33600
MOHAMMEDI Kamel, Pr, kamel.mohammedi@chu-bordeaux.fr
- Recruiting
HCL - Hôpital Lyon sud
Pierre-Bénite
Julien VOUILLARMET, Dr, julien.vouillarmet@chu-lyon.fr
- Recruiting
CHU de la Milétrie
Poitiers, 86021
TORREMOCHA Florence, Dr, Florence.TORREMOCHA@chu-poitiers.fr
- Recruiting
CHU de Rouen
Rouen
Gaëtan PREVOST, Pr, Gaetan.Prevost@chu-rouen.fr
- Recruiting
Centre Hospitalier Saint Benoit
Saint-Benoît, 97470
Pravesh Kumar GUNESS, pk.guness@gher.fr
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé
Cyril GARCIA, Dr, cyril1.garcia@intradef.gouv.fr
- Recruiting
Maison de Santé Protestante Bagatelle - Hôpital Bagatelle
Talence, 33404
Pascal TOUSSAINT, Dr, p.toussaint@mspb.com
- Recruiting
CHU de Toulouse - Hôpital Rangueil
Toulouse
Pierre GOURDY, Pr, gourdy.p@chu-toulouse.fr
About this study
Official title: Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease.
The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.
Read the detailed description
Diabetic foot ulcer (DFU) is one of the major complications frequently observed in patients with diabetes. DFU is the leading cause of non-traumatic lower-limb amputation (LLA), and it is associated with cognitive decline, worsening quality of life and substantial economic impact on French healthcare system. DFU is also associated with excess risk of premature death with significant decrease in life expectancy despite major improvement in medical care during last decades. The hypothesis of the study is that this worse prognosis seen in DFU patients may not be fully explained by a high cardiovascular risk, but mainly linked to different causes, including inflammatory, infectious and malignant conditions.
In addition, to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants, the investigators will also assess all changes in health-related quality of life (HRQoL), and the economic impact related to DFU (cost of illness study) for the French healthcare system, using SNDS claims databases. A 3-year inclusion period will start during 2020, and each participant will be followed for 5 years or until death.
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes mellitus, Lower-limb amputation, Wound, Health-related quality of life, Cost-of-illness
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
DFU risk score
Construct a DFU risk score equation of all-death will be computed to determine individuals with the higher risk of worse outcomes.
Measured: 5 years after inclusion
Secondary outcomes (5)
Survival without active index DFU
Measured: At 3 and 12 months after inclusion day
Survival without recurrent index DFU
Measured: At 12, 24, 36, 48, 60 months after inclusion day
Survival without major adverse limb events (MALE)
MALE is a composite of foot infection, non-traumatic lower-limb amputation (LLA), requirement of revascularization, whichever comes first. These components will be also considered individually.
Measured: 5 years after inclusion
Survival without major macrovascular events (MACE)
MACE is a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death, whichever comes first.
Measured: 5 years after inclusion
Survival without major microvascular events (MICE)
MICE is a composite of new-onset persistent macroalbuminuria, sustained 40% declined eGFR from baseline, ESRD, severe diabetic retinopathy or macular oedema requiring laser photocoagulation or intravitreal therapies, or diabetes-related blindness in either eye, whichever comes first.
Measured: 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start24 Nov 2021
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533152
- Sponsor's protocol ID
- CHUBX 2019/70
- Acronym
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2020
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
- ClinicalTrials.gov ID
- NCT04533152
- Acronym / sponsor ID
- PDF / CHUBX 2019/70
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes mellitus, Lower-limb amputation, Wound, Health-related quality of life, Cost-of-illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease.
The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.
Detailed description
Diabetic foot ulcer (DFU) is one of the major complications frequently observed in patients with diabetes. DFU is the leading cause of non-traumatic lower-limb amputation (LLA), and it is associated with cognitive decline, worsening quality of life and substantial economic impact on French healthcare system. DFU is also associated with excess risk of premature death with significant decrease in life expectancy despite major improvement in medical care during last decades. The hypothesis of the study is that this worse prognosis seen in DFU patients may not be fully explained by a high cardiovascular risk, but mainly linked to different causes, including inflammatory, infectious and malignant conditions.
In addition, to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants, the investigators will also assess all changes in health-related quality of life (HRQoL), and the economic impact related to DFU (cost of illness study) for the French healthcare system, using SNDS claims databases. A 3-year inclusion period will start during 2020, and each participant will be followed for 5 years or until death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DFU risk score
Time frame: 5 years after inclusion
Construct a DFU risk score equation of all-death will be computed to determine individuals with the higher risk of worse outcomes.
5 secondary outcomes
Survival without active index DFU
Time frame: At 3 and 12 months after inclusion day
Survival without recurrent index DFU
Time frame: At 12, 24, 36, 48, 60 months after inclusion day
Survival without major adverse limb events (MALE)
Time frame: 5 years after inclusion
Survival without major macrovascular events (MACE)
Time frame: 5 years after inclusion
Survival without major microvascular events (MICE)
Time frame: 5 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent RIGALLEAU, Pr contact
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by University Hospital, Bordeaux at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamel MOHAMMEDI, Pr (5 57 65 60 78 ext. +33, kamel.mohammedi@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFU risk score (time frame: 5 years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.