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Clinical Trials/EUCTR2015-000510-22-ES
EUCTR2015-000510-22-ES
Active, not recruiting
Phase 1

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 sites220 target enrollmentMay 8, 2015
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ConditionsDiabetic foot ulcersMedDRA version: 18.0Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetic foot ulcers
Sponsor
Banc de Sang i Teixits
Enrollment
220
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Not specified

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