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

Phase 1

• Conditions: Diabetic Foot; Diabetes Complications

• Registration Number: NCT00292357
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-15
• Status Verified: 2007-04
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Healing velocity
Safety and Feasibility

Trial Locations

Locations (1)

Medizinische Klinik 1, Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany