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

Completed

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

• Registration Number: NCT02168348
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-20
• Primary Completion: 2017-01-17
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients with a lesion on the foot	biological examination at consultations at 3 and 6 months	-

Primary Outcome Measures

Name	Time	Method
Percentage of healed lesions	After 24 weeks of follow-up

Secondary Outcome Measures

Name	Time	Method
Number of malnourished patients according to HAS 2003 and 2007 criteria	At inclusion

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France