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Autologous Endothelial Progenitor Cells Treatment of Diabetic Foot

NCT02474381 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-06-17

No results posted yet for this study

Summary

The vascular pathologic basis of diabetic foot include arterial obstruction and micro-circulation defects.The latest technology of arterial reconstruction can only rebuild blood flow of anterior,posterior tibial artery and peroneal artery.Endothelial progenitor cells have been proved to integrate into damaged vascular endothelium and improve vasculogenesis in vitro and in animal experiment.Therefore endothelial progenitor cells are supposed to improve the micro-circulation status of diabetic foot patients.In this trial,the investigators recuit diabetic foot patients with infrapopliteal arterial obstructive disease,treat them with autologous endothelial progenitor cells after intraluminal intervention,and observe the therapeutic efficacy comparing to single intraluminal intervention.

Conditions

  • Diabetic Foot

Interventions

BIOLOGICAL

EPCs plus PTA

Intra-arterial infusion of autologous CD133+ cells on diabetic subjects with PAD,plus angioplasty

DEVICE

Single PTA

Angioplasty of arteries below tibial plateau level only

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Shanghai 10th People's Hospital

    lead OTHER

Principal Investigators

  • Chenhui Lu, Ph.D · Shanghai 10th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • China

Study Locations

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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 NCT02474381 on ClinicalTrials.gov