Prognostic Determinants in Patients With Diabetic Foot Ulcer.

ClinicalTrials.gov ID

NCT04533152

Lead Sponsor

University Hospital, BordeauxOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Jan 15, 2026Actual

Start Date

Nov 24, 2021Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

Nov 2029Estimated

Official Title

Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.

Brief 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.

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.

• Diabetic Foot Ulcer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, BordeauxOTHER

Collaborators

Fondation Francophone pour la Recherche sur le DiabeteOTHER

Gaetan.Prevost@chu-rouen.fr

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