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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00292357
First received: February 14, 2006
Last updated: January 15, 2010
Last verified: April 2007
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Safety and Feasibility
  • Healing velocity

Estimated Enrollment: 40
  Eligibility

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00292357     History of Changes
Other Study ID Numbers: HD-Med1-01/06
Study First Received: February 14, 2006
Last Updated: January 15, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on September 22, 2014