Impact of Malnutrition on the Healing of Foot Lesions in... | NCT02168348

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

NCT02168348

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 9, 2026Actual

Enrollment

75Actual

Phase

Not provided

Conditions

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

Interventions

biological examination at consultations at 3 and 6 months

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2013Actual

Primary Completion Date

Jan 17, 2017Actual

Completion Date

Not provided

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 19, 2014

First Posted Date

Jun 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Label	Type	Description	Intervention Names
Diabetic patients with a lesion on the foot			Other: biological examination at consultations at 3 and 6 months

Name	Type	Description	Arm Group Labels	Other Names
biological examination at consultations at 3 and 6 months	Other		Diabetic patients with a lesion on the foot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of healed lesions		After 24 weeks of follow-up

Secondary Outcomes

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

Other Outcomes

Measure	Description	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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de DIJON		Dijon		21079	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30284047	Result	Rouland A, Fourmont C, Sberna AL, Aho Glele LS, Mouillot T, Simoneau I, Verges B, Petit JM, Bouillet B. Malnutrition in type 2 diabetic patients does not affect healing of foot ulcers. Acta Diabetol. 2019 Feb;56(2):171-176. doi: 10.1007/s00592-018-1233-9. Epub 2018 Oct 3.