NCT00442143

Brief Summary

The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 23, 2010

Status Verified

March 1, 2007

First QC Date

February 28, 2007

Last Update Submit

July 22, 2010

Conditions

Ischemia

Keywords

CLIPAODSevere lower limb ischemia

Outcome Measures

Primary Outcomes (5)

  • Transcutaneous oxygen pressure

  • 1st toe blood pressure (strain gauge)

  • Ankle blood pressure

  • Wound healing

  • Pain

Secondary Outcomes (2)

  • amputation

  • Infection

Interventions

Stem cell implantationPROCEDURE

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ankle blood pressure \< 70 mmgHG
  • Either pain at rest and/or ischemic wound
  • No possible surgical treatment

You may not qualify if:

  • Infection
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of endocrinology M, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Moustapha Kassem, MD

    Department of endocrinology M, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malthe AM Kristiansen, MD

CONTACT

+4565504081mkristiansen@health.sdu.dk

Study Design

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

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

January 1, 2007

Study Completion

December 1, 2007

Last Updated

July 23, 2010

Record last verified: 2007-03

Locations

DK(1)