CLINICAL EFFICACY OF PLATELET GEL FROM CORD BLOOD FOR THE TREATMENT OF DIABETIC FOOT ULCERS - CLINICAL EFFICACY OF CBPG FOR THE TREATMENT OF DIABETIC FOOT ULCERS

Banc de Sang i Teixits0 个研究点目标入组 220 人开始时间: 2015年5月8日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•1. Patients >18 year with diabetic ulcer
•2. Ulcer dimensions (5cm2 < X < 20cm2)
•3. Undermining or tunneling
•4. TUC I and II C. At the time of 1st application, ulcer is not clinically infected (smelly, tissue, hot and flushed perilesional edematous)
•5. General conditions of Patient:
•a. Controlled diabetes (HbA1c <9)
•b. Albumin > 2.5g/dl
•6. Informed consent
•7. Patient able to understand the conditions of the study and to participate for its entire duration
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Patient with serious medical conditions that contraindicate the patient's participation in the study (tumors, severe chronic renal failure, autoimmune diseases, severe ischemic heart disease)
•2. Patient with uncontrolled diabetes mellitus (HbA1c >9) or severe metabolic diseases
•3. Heel ulcer and outcomes of amputation
•4. Patient with present clinical infection
•5. Bone exposure
•6. Patient taking or having taken chronically drugs that can affect the metabolism, and in general regeneration and tissue repair (bisphosphonates, chemotherapy, chronic therapy with corticosteroids)
•7. Use of experimental drugs
•8. Patients not able to follow the procedures of the Protocol and to sign the informed consent.
•9. Current pregnancy
•10. Negative Pressure (possible use in control arm patients)

发起方