Diabetic FootPhase 1NCT00292357
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers
A Phase 1 study testing Application of autologous bone marrow in people with Diabetic Foot and Diabetes Complications, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot, Diabetes Complications
- What is being tested?
- Application of autologous bone marrow
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes mellitus
- chronic non-healing foot ulcers (>4weeks)
Who cannot join
- Charcot foot
- Non-diabetic ulcers
- Ulcers healing under conventional therapy
- Sepsis
- Hematologic disorders
- Pregnancy
- Acute inflammatory disorders
- Chemotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medizinische Klinik 1, Universitätsklinikum Heidelberg
Heidelberg, 69120
Per M Humpert, MD, +49 6221 56 ext. 8787, per.humpert@med.uni-heidelberg.de
About this study
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.
- Conditions
- Diabetic Foot, Diabetes Complications
- Being tested
- Application of autologous bone marrow
- Medical subject headings
- Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of autologous bone marrowProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility
Healing velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Peter Nawroth, MD, Principal investigator, University of Heidelberg, Dept. Medicine 1, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292357
- Sponsor's protocol ID
- HD-Med1-01/06
- Status last verified
- Apr 2007
- First submitted
- 14 Feb 2006
- Last updated
- 18 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00292357
- Acronym / sponsor ID
- HD-Med1-01/06
- Conditions
- Diabetic Foot, Diabetes Complications
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus
- chronic non-healing foot ulcers (>4weeks)
Key exclusion criteria (8 listed)
- Charcot foot
- Non-diabetic ulcers
- Ulcers healing under conventional therapy
- Sepsis
- Hematologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of autologous bone marrow | Procedure or surgery | – |
Primary outcome
Safety and Feasibility
Healing velocity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
Related trials for Diabetic Foot
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nawroth, MD principal investigator
University of Heidelberg, Dept. Medicine 1, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Application of autologous bone marrow in people with Diabetic Foot and Diabetes Complications, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per Humpert, MD (+49 6221 56 ext. 8787, per.humpert@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2010.