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Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2

NCT02943486 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-10-24

No results posted yet for this study

Summary

The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults. A third of the participants will receive dac-MSCs and Triticum vulgare (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and the last third only Fitosimoline. This study will be a randomized, blind, and parallel and controlled-group trial.

Conditions

  • Foot Ulcer, Diabetic

Interventions

OTHER

dac-MSCs

Cell-free therapy

OTHER

MSCs

Cell-based therapy

DRUG

Fitostimoline

Triticum vulgare

Sponsors & Collaborators

  • Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

    collaborator OTHER

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Universidad Autónoma de Bucaramanga

    lead OTHER

Principal Investigators

  • Claudia L Sossa-Melo, MD · Universidad Autónoma de Bucaramanga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-06-30
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02943486 on ClinicalTrials.gov