Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot Clinical Trial
Official title:
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
| NCT number | NCT02168348 |
| Other study ID # | BOUILLET 2013 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 26, 2013 |
| Verified date | May 2019 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | |
| Est. primary completion date | January 17, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de DIJON | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of healed lesions during the follow-up | At 2, 4, 8, 12, 16 and 20 weeks | ||
| Other | Number of malnourished patients at 12 and 24 weeks | At 12 and 24 weeks | ||
| Primary | Percentage of healed lesions | After 24 weeks of follow-up | ||
| Secondary | Number of malnourished patients according to HAS 2003 and 2007 criteria | At inclusion |