Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

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

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

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

Probability Sample

Study Population

Patients with type 1 or 2 diabetes who have a lesion situated on a toe or on the plantar or dorsal side of the foot

Description

Inclusion Criteria:

  • Patients who have provided oral consent
  • Patients older than 18
  • Patients with type 1 or 2 diabetes
  • Patients who can be followed-up in the context of consultations for diabetic foot at the endocrinology, diabetology and metabolic diseases unit of Dijon CHU.
  • Lesion situated on a toe or on the plantar or dorsal side of the foot
  • Lesion that has evolved for 1 to 24 months

Exclusion Criteria:

  • Adult under guardianship
  • Patient without national health insurance
  • Pregnant or breast-feeding women
  • Patients with progressive cancer
  • Patients with terminal renal insufficiency on dialysis
  • Patient with severe respiratory insufficiency
  • Patients with terminal heart failure
  • Patients with severe liver failure
  • Patients with immunodepriession (treatement with immunosuppressants, long-term corticotherapy, diseases leading to immunodepression)
  • Patients with nephrotic syndrome (hypoalbuminemia)
  • Patientswith a chronic inflammatory syndrome
  • Alcohol consumption greater than 4 glasses per day
  • Systemic infection uncontrolled by antibiotics
  • Infected lesion with systemic repercussions
  • Charcot foot
  • Patients taking part or who have planned to take part in another clinical trial
  • Severe disease affecting survival in the short term
  • Lesion on an amputation
  • Lesion of the ankle or leg

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patients with a lesion on the foot
Other: biological examination at consultations at 3 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of healed lesions
Time Frame: After 24 weeks of follow-up
After 24 weeks of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of malnourished patients according to HAS 2003 and 2007 criteria
Time Frame: At inclusion
At inclusion

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of healed lesions during the follow-up
Time Frame: At 2, 4, 8, 12, 16 and 20 weeks
At 2, 4, 8, 12, 16 and 20 weeks
Number of malnourished patients at 12 and 24 weeks
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 26, 2013

Primary Completion (Actual)

January 17, 2017

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimated)

June 20, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOUILLET 2013

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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