Patients With Type 1 or 2 DiabetesNCT02168348
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
An observational study of Patients With Type 1 or 2 Diabetes and Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Type 1 or 2 Diabetes, Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot
- What is being tested?
- biological examination at consultations at 3 and 6 months
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2013to 17 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.
- Conditions
- Patients With Type 1 or 2 Diabetes, Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot
- Being tested
- biological examination at consultations at 3 and 6 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological examination at consultations at 3 and 6 monthsOther
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with a lesion on the foot | Not described Receives: Other: biological examination at consultations at 3 and 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healed lesions
Measured: After 24 weeks of follow-up
Secondary outcomes (1)
Number of malnourished patients according to HAS 2003 and 2007 criteria
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study start26 Nov 2013
- Primary completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Type 1 or 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168348
- Sponsor's protocol ID
- BOUILLET 2013
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2014
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
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.
PubMed 30284047
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02168348
- Acronym / sponsor ID
- BOUILLET 2013
- Conditions
- Patients With Type 1 or 2 Diabetes, Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with a lesion on the foot | – | Other: biological examination at consultations at 3 and 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- Adult under guardianship
- Patient without national health insurance
- Pregnant or breast-feeding women
- Patients with progressive cancer
- Patients with terminal renal insufficiency on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological examination at consultations at 3 and 6 months | Other | Diabetic patients with a lesion on the foot |
Primary outcome
Percentage of healed lesions
Time frame: After 24 weeks of follow-up
1 secondary outcome
Number of malnourished patients according to HAS 2003 and 2007 criteria
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 30284047Rouland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Type 1 or 2 Diabetes and Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of healed lesions (time frame: After 24 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.