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

Heidelberg University

Status and phase: Unknown; Phase 1

Conditions: Diabetes Complications; Diabetic Foot

Treatments: Procedure: Application of autologous bone marrow

Study type: Interventional

Funder types: Other

Identifiers

NCT00292357

HD-Med1-01/06

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)