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

NCT ID: NCT00292357

Last Updated: 2010-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Diabetic Foot Diabetes Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Application of autologous bone marrow

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Peter Nawroth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg, Dept. Medicine 1, Germany

Locations

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Medizinische Klinik 1, Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Per Humpert, MD

Role: CONTACT

+49 6221 56 ext. 8787

Facility Contacts

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Per M Humpert, MD

Role: primary

+49 6221 56 ext. 8787

Other Identifiers

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HD-Med1-01/06

Identifier Type: -

Identifier Source: org_study_id

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