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

Phase 1

Conditions: Diabetic foot ulcers
MedDRA version: 18.0Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2015-000510-22-ES

Lead Sponsor: Banc de Sang i Teixits

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To increase ulcer?s healing from 40% in controls to >60% in treated patients;Secondary Objective: Percent skin ulcer closure area.<br><br>Number and type of adverse events that will occur in diabetic patients during treatment period.<br><br>Cost of treatment.;Primary end point(s): Percent reduction (100% = healing) of ulcer's size;Timepoint(s) of evaluation of this end point: Week 4 of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ulcer's infection, osteomyelitis, amputation, AE monitored with CTCAE v 3.0;Timepoint(s) of evaluation of this end point: Week 4 of treatment