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NCT00292357 Clinical Trial

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

Diabetic Foot Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00292357
Other study ID # HD-Med1-01/06
Secondary ID
Status Recruiting
Phase Phase 1
First received February 14, 2006
Last updated January 15, 2010

Study information
Verified date April 2007
Source Heidelberg University
Contact Per Humpert, MD
Phone +49 6221 56
Email per.humpert@med.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Application of autologous bone marrow

Locations
Country Name City State
Germany Medizinische Klinik 1, Universitätsklinikum Heidelberg Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Feasibility
Primary Healing velocity
See also
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