NCT00292357

Brief Summary

Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

January 18, 2010

Status Verified

April 1, 2007

First QC Date

February 14, 2006

Last Update Submit

January 15, 2010

Conditions

Diabetic FootDiabetes Complications

Outcome Measures

Primary Outcomes (2)

  • Safety and Feasibility

  • Healing velocity

Interventions

Application of autologous bone marrowPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus
  • chronic non-healing foot ulcers (\>4weeks)

You may not qualify if:

  • Charcot foot
  • Non-diabetic ulcers
  • Ulcers healing under conventional therapy
  • Sepsis
  • Hematologic disorders
  • Pregnancy
  • Acute inflammatory disorders
  • Chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik 1, Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes Complications

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peter Nawroth, MD

    University of Heidelberg, Dept. Medicine 1, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Humpert, MD

CONTACT

+49 6221 56per.humpert@med.uni-heidelberg.de

Study Design

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

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Last Updated

January 18, 2010

Record last verified: 2007-04

Locations

DE(1)