NCT02474381

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 17, 2015

Status Verified

December 1, 2012

Enrollment Period

3.9 years

First QC Date

June 10, 2015

Last Update Submit

June 12, 2015

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Infrapopliteal arterial patency of the affected extremity

    Ultrasonography deployed to assess the patency

    Every 3 month until 1year after the treatment

Secondary Outcomes (1)

  • Amputation rate of the affected extremity

    At 6 month and 1 year after the treatment

Study Arms (2)

EPCs plus PTA

EXPERIMENTAL

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

Biological: EPCs plus PTA

Single PTA

ACTIVE COMPARATOR

Angioplasty of arteries below tibial plateau level only

Device: Single PTA

Interventions

EPCs plus PTABIOLOGICAL

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

EPCs plus PTA
Single PTADEVICE

Angioplasty of arteries below tibial plateau level only

Single PTA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic PAD patients aged ≥18 years with Rutherford categories 2 to 5

You may not qualify if:

  • Hemoglobin \< 10 mg/dl
  • Creatinine clearance \< 30 ml/min
  • Previous history of stem/progenitor cell therapy
  • Paralysis because of central neural system disease
  • Accidental amputation or bone fracture of target limb because of trauma after entry
  • Stop of anti-platelet medication after entry
  • Smoking or re-smoking after entry
  • Malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth people's hospital, Tongji university

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (2)

  • Wu T, Liu Y, Wang B, Li G. The roles of mesenchymal stem cells in tissue repair and disease modification. Curr Stem Cell Res Ther. 2014;9(5):424-31. doi: 10.2174/1574888x09666140616125446.

    PMID: 24998241BACKGROUND

  • Invernici G, Emanueli C, Madeddu P, Cristini S, Gadau S, Benetti A, Ciusani E, Stassi G, Siragusa M, Nicosia R, Peschle C, Fascio U, Colombo A, Rizzuti T, Parati E, Alessandri G. Human fetal aorta contains vascular progenitor cells capable of inducing vasculogenesis, angiogenesis, and myogenesis in vitro and in a murine model of peripheral ischemia. Am J Pathol. 2007 Jun;170(6):1879-92. doi: 10.2353/ajpath.2007.060646.

    PMID: 17525256RESULT

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Chenhui Lu, Ph.D

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maoquan Li, Prof.

CONTACT

02166313506cjr.limaoquan@vip.163.com

Shilong Han, Ph.D

CONTACT

02166313506hanshilong86@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Interventional Department

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 17, 2015

Study Start

December 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 17, 2015

Record last verified: 2012-12

Locations

CN(1)