Diabetic foot ulcers (grade 3A according to the University of Texas classification) Skin and Connective Tissue Diseases
Conditions
Interventions
The choice of arm in which each patient are enrolled following their inclusion in the study is defined by a randomisation process known as "per block" via Microsoft Access. This is a method for obtain
Sponsors
Regen Lab SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetic patients, type 1 or 2, aged 18 years or older, with one or more neuropathic ulcers located on the plantar surface of the foot, on the plantar and/or dorsal surface of the toes, grade 3A according to the University of Texas classification, with a surface area of less than 5 cm² and a depth of more than 5 mm, and with infection and bone complications (osteitis, shock or bony sequestrum), are treated successfully before inclusion 2. Patients on antiplatelet therapy (Plavix, Sindron, low molecular weight heparin, aspirin, etc) may participate in the study 3. Have signed a free, informed consent form 4. Able to understand the requirements of the trial 5. Patients treated with corticosteroids are included but stratified separately 6. Since the effects of autologous platelet gel prepared with RegenKit®-BCT on the foetus are not known, women of childbearing age may participate in the study, but must use a reliable method of contraception (pill, dual mechanical contraceptive method such as an IUD, diaphragm, etc, in combination with a condom) for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Patients participating in or who have participated in another clinical study within the last 2 months 2. Patients with a history of allergy to a component of the formulation being tested 3. Patients with inherited or acquired haematological or coagulation disorders, such as platelet dysfunction syndrome, critical thrombocytopenia, coagulation disorders, sickle cell disease, etc 4. Anaemic patients (HGB <10 g/dl) 5. Patients with clear clinical signs of acute uncontrolled local or general infection 6. Patients with autoimmune disease (Hashimoto, rheumatoid arthritis, lupus etc) 7. Ulcer whose area has decreased by 20% at the inclusion/randomisation visit compared to the area measured at the screening visit 8. Patients who are not compliant in wound off-loading 9. Patients with malignant disease, particularly with haematological or bone involvement, or metastatic disease 10. Patients on chemotherapy 11. Any other reason which, in the opinion of the investigator, could interfere with the proper conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ulcers healed 6 weeks after the first treatment, measured by qualitative assessment of the wound/healing at week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The average healing time expressed in days, measured by qualitative assessment of the wound/healing at the end of treatment visit (ETV) 2. The re-epithelialisation level, evaluated on a 5-degree scale (0=absent; 1=mild; 2=moderate; 3=significant; 4=very significant) at each study treatment visit (STV) during the 6 weeks of treatment, at the end of treatment visit (ETV) and at the end of study visit (ESV) 3. Tolerance assessed globally with a 10-point VAS at each study treatment visit (STV) during the 6 weeks of treatment, at the end of treatment visit (ETV) and at the end of study visit (ESV) 4. The degree of acceptability of the treatment by the patient is assessed as very satisfactory, fairly satisfactory unsatisfactory or not satisfactory at all at each study treatment visit (STV) during the 6 weeks of treatment, at the end of treatment visit (ETV) and at the end of study visit (ESV) 5. The economic merits of the treatment estimated a posteriori based on (1) the cost of hospital visits (medical and nursing procedures during the inclusion, treatment and follow-up visits), (2) the cost associated with the follow-up of patients at home by specialized nurses (limited to the period between randomization and the end of treatment) and (3) costs for the material used for care (dressings, RegenKit-BCT Plus, antibiotic treatment when required, off-loading and transport of patients), for the maximum 6-week treatment period as defined in the protocol to which two end-of-study visits are added | — |
Countries
France
Outcome results
None listed