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

The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.

Study Overview

• Status: Completed
• Conditions: Patients With Type 1 or 2 Diabetes; Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot
• Intervention / Treatment: Other: biological examination at consultations at 3 and 6 months

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

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	After 24 weeks of follow-up

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

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 (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BOUILLET 2013