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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168348
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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

Condition or disease Intervention/treatment
Patients With Type 1 or 2 Diabetes Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot Other: biological examination at consultations at 3 and 6 months

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
Actual Study Start Date : November 26, 2013
Actual Primary Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of healed lesions [ Time Frame: After 24 weeks of follow-up ]

Secondary Outcome Measures :
  1. Number of malnourished patients according to HAS 2003 and 2007 criteria [ Time Frame: At inclusion ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168348


Locations
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France
CHU de DIJON
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02168348    
Other Study ID Numbers: BOUILLET 2013
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders