NCT01216865

Brief Summary

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 13, 2010

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

October 6, 2010

Last Update Submit

October 12, 2010

Conditions

Diabetic FootCritical Limb IschemiaMesenchymal Stem CellsUmbilical Cord

Keywords

Diabetic footcritical limb ischemiamesenchymal stem cellsumbilical cord

Outcome Measures

Primary Outcomes (1)

  • Angiographic evaluation of angiogenesis at ischemic limb

    6 months

Secondary Outcomes (5)

  • Pain

    3 months

  • Ankle-Brachial pressure index

    3 months

  • Wound healing (wound size, wound stage)

    3 months

  • Walking distance

    3 months

  • Rate and extent of amputations

    6 months

Study Arms (2)

umbilical cord mesenchymal stem cells

EXPERIMENTAL

Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Biological: umbilical cord mesenchymal stem cells

Standard Therapy

ACTIVE COMPARATOR

Any therapy for diabetic foot which is routinely practiced and accepted in China

Drug: Standard Therapy

Interventions

umbilical cord mesenchymal stem cellsBIOLOGICAL

5\*10/7 per ischemic limb

Also known as: mesenchymal stem cells
umbilical cord mesenchymal stem cells
Standard TherapyDRUG

Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Also known as: Drug therapy
Standard Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus Type 2
  • Age 18 - 75 years
  • Subject has an Ankle-brachial index \< 0.9
  • Subject has had previous conservative treatment which resulted in little or no improvement
  • Subject has had no stem cell treatment within the past 6 months
  • No sufficient response to best standard care delivered for six weeks.
  • No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
  • Signed informed consent
  • Absence of life-threatening complications from the ischemic limb
  • Life expectancy more than 2 years
  • Negative pregnancy test when applicable

You may not qualify if:

  • Diabetic retinopathy
  • History of neoplasm or hematological disease
  • Uncontrolled high blood pressure (\>180/110)
  • Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
  • Malignant ventricular arrythmia
  • Deep venous thrombosis during the last 3 months
  • Active bacterial infection
  • Body mass index \> 35 Kg/m2
  • Stroke or myocardial infarction during the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Diabetic FootChronic Limb-Threatening Ischemia

Interventions

Standard of CareDrug Therapy

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationTherapeutics

Study Officials

  • Yangang Wang, MD Phd

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR

Central Study Contacts

Jianxia Hu, MD

CONTACT

86-0532-82911676qdyxyhjx@126.com

Hong Gao, MS

CONTACT

86-0532-82911676honggaogloria@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

October 13, 2010

Record last verified: 2009-01

Locations

CN(1)