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Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292357
First Posted: February 15, 2006
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
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.

Condition Intervention Phase
Diabetic Foot Diabetes Complications Procedure: Application of autologous bone marrow Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Safety and Feasibility
  • Healing velocity

Estimated Enrollment: 40
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Charcot foot
  • Non-diabetic ulcers
  • Ulcers healing under conventional therapy
  • Sepsis
  • Hematologic disorders
  • Pregnancy
  • Acute inflammatory disorders
  • Chemotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292357


Contacts
Contact: Per Humpert, MD +49 6221 56 ext 8787 per.humpert@med.uni-heidelberg.de

Locations
Germany
Medizinische Klinik 1, Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Per M Humpert, MD    +49 6221 56 ext 8787    per.humpert@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Peter Nawroth, MD University of Heidelberg, Dept. Medicine 1, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00292357     History of Changes
Other Study ID Numbers: HD-Med1-01/06
First Submitted: February 14, 2006
First Posted: February 15, 2006
Last Update Posted: January 18, 2010
Last Verified: April 2007

Additional relevant MeSH terms:
Diabetic Foot
Diabetes Complications
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies