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

Primary Purpose

Diabetic Foot, Diabetes Complications

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Application of autologous bone marrow

About this trial

This is an interventional treatment trial for Diabetic Foot

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medizinische Klinik 1, Universitätsklinikum HeidelbergRecruiting

Outcomes

Primary Outcome Measures

Safety and Feasibility

Healing velocity

Secondary Outcome Measures

Full Information

NCT ID

NCT00292357

First Posted

February 14, 2006

Last Updated

January 15, 2010

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00292357

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot, Diabetes Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Application of autologous bone marrow

Primary Outcome Measure Information:

Title

Safety and Feasibility

Title

Healing velocity

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Per Humpert, MD

Phone

+49 6221 56

Ext

8787

per.humpert@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Nawroth, MD

Organizational Affiliation

University of Heidelberg, Dept. Medicine 1, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medizinische Klinik 1, Universitätsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Per M Humpert, MD

Phone

+49 6221 56

Ext

8787

per.humpert@med.uni-heidelberg.de

12. IPD Sharing Statement

Learn more about this trial

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

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