Prognostic Determinants in Patients With Diabetic Foot Ulcer. (PDF)

July 18, 2023 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival without active index DFU
Time Frame: At 3 and 12 months after inclusion day
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
At 12, 24, 36, 48, 60 months after inclusion day
Survival without major adverse limb events (MALE)
Time Frame: 5 years after inclusion
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.
5 years after inclusion
Survival without major macrovascular events (MACE)
Time Frame: 5 years after inclusion
MACE is a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death, whichever comes first.
5 years after inclusion
Survival without major microvascular events (MICE)
Time Frame: 5 years after inclusion
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.
5 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Fondation Francophone pour la Recherche sur le Diabete

Investigators

  • Study Chair: Nathalie PREAUBERT-HAYES, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/70

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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