Looking at what affects long-term outcomes in people with diabetic foot ulcers
Follows adults with diabetic foot ulcer in France to study death and its causes.
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- France and Martinique26 sites in 2 countriesChoose a country to see its sites
- Trial code
- Registry title
- Prognostic Determinants in Patients With Diabetic Foot Ulcer.
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 24 Nov 2021
- Expected to end
- Nov 2029
- Type of study
- Observational
- Record updated
- 15 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetes who have a diabetic foot ulcer. It follows them over time to study survival over 5 years and what affects it.
- Age
- 18 Years and older
- Sex
- All
- Disease stage
- A foot skin ulcer or open wound of at least 5 mm across, below the ankle bone, caused by diabetes complications. After an earlier amputation, the stump counts as the main wound.
Main reasons for not taking part
- Poor blood flow in the leg without an open skin wound
- Foot infection without an open skin wound
- Another illness that makes taking part in an observational study impossible
- Pregnancy or breastfeeding
- Under guardianship or curatorship, or in prison
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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 take part
- Foot infection without open skin wound,
- Intercurrent disease prohibiting participation in an observational study,
- Acute or chronic lower-limb ischemia without open skin wound,
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
- Plain-language title
- Looking at what affects long-term outcomes in people with diabetic foot ulcersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 15 January 2026