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

NCT ID: NCT02168348

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-26

Brief Summary

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

Detailed Description

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Conditions

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Patients With Type 1 or 2 Diabetes Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients with a lesion on the foot

biological examination at consultations at 3 and 6 months

Intervention Type OTHER

Interventions

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biological examination at consultations at 3 and 6 months

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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BOUILLET 2013

Identifier Type: -

Identifier Source: org_study_id

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