Study of the efficacy of autologous platelet gel obtained with RegenKit®-BCT Plus for the treatment of chronic neuropathic foot ulcers in diabetic patients

Regen Lab SA0 个研究点目标入组 96 人开始时间: 2021年11月11日最近更新: 2021年11月22日

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•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

•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

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