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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
Information provided by:
Heidelberg University Identifier:
First received: February 14, 2006
Last updated: January 15, 2010
Last verified: April 2007
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00292357

Contact: Per Humpert, MD +49 6221 56 ext 8787

Medizinische Klinik 1, Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Per M Humpert, MD    +49 6221 56 ext 8787   
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Peter Nawroth, MD University of Heidelberg, Dept. Medicine 1, Germany
  More Information Identifier: NCT00292357     History of Changes
Other Study ID Numbers: HD-Med1-01/06
Study First Received: February 14, 2006
Last Updated: January 15, 2010

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 processed this record on September 19, 2017