NCT02168348CompletedNot Applicable
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
Centre Hospitalier Universitaire Dijon1 site in 1 country75 target enrollmentStarted: November 26, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Percentage of healed lesions
Study Overview
Brief Summary
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diabetic patients with a lesion on the foot
Intervention: biological examination at consultations at 3 and 6 months (Other)
Outcomes
Primary Outcomes
Percentage of healed lesions
Time Frame: After 24 weeks of follow-up
Secondary Outcomes
- Number of malnourished patients according to HAS 2003 and 2007 criteria(At inclusion)
Investigators
Study Sites (1)
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