DIABETIC FOOT ULCER
Conditions
Interventions
Product Name: FRACTION VASCULAIRE STROMALE AUTOLOGUE DU TISSU ADIPEUX
Product Code: FVS
Pharmaceutical Form: Suspension for injection
Other descriptive name: Autologous adipose tissue-derived stroma
Sponsors
Assistance Publique Hôpitaux de Marseille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed Consent Form Information and Signature Female or male patient 18 years of age or older Type 1 or 2 diabetes mellitus patient with 10% HbA1C less than 1 month old (if this result is not available at the inclusion visit, analysis should be done during the 15-day assessment period) Affiliation to social security. Patient can be followed by the same team of investigators throughout the study. Patient willing to wear the discharge system daily and the prescribed dressing throughout the study. Patient with BMI 18.5 Kg/m² (in order to have sufficient fat tissue) Good overall condition, based on history and clinical examination Women of reproductive age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Pregnant or nursing woman or woman of childbearing age without effective contraception, Known hypersensitivity to human albumin. Surgical revascularization or surgery of the lower limbs for less than a month, Ischemic accident (stroke, myocardial infarction) within 3 months before inclusion Patient with kidney failure requiring dialysis Systemic infection not controlled by appropriate antibiotic treatment Patient with documented osteomyelitis Patient with active neoplasia, treated with radiotherapy, chemotherapy, hormone therapy or immunosuppressive therapy. Patient treated for chronic pathology requiring high-dose corticosteroid therapy ( 40 mg/d prednisolone or equivalent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the effectiveness of local SVF injection in the treatment of UPD refractory to conventional well-conducted treatment (International Working group) in week 20.;Secondary Objective: Secondary objectives associated with treatment effectiveness are: 5) the time to complete wound healing (based on the wound overlay) from the FVS (J0) injection to the complete epidermis. 6) the regression/change in the area of the wound in absolute and relative values between the initial assessment and the end of treatment (S20) or premature cessation (based on the layer of the wound).;Primary end point(s): the effectiveness of local SVF injection (% % of wounds completely healed by week 20 (S20) post-injection);Timepoint(s) of evaluation of this end point: 20 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to complete wound healing;Timepoint(s) of evaluation of this end point: 20WEEKS | — |
Countries
France
Contacts
Public ContactPROJECT MANAGER
AP HM
Outcome results
None listed