Diabetic FootPhase 2NCT00537498
Urokinase Therapy in Diabetic Foot Syndrome
A Phase 2 study testing Urokinase in people with Diabetic Foot and Arterial Occlusive Disease, run by medac GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- What is being tested?
- Urokinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2002to Dec 2006
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- angiopathic or angioneuropathic diabetic foot lesions
- critical limb ischemia
- no surgical or interventional treatment option
Who cannot join
- feasibility of vascular surgery or angioplasty
- prior treatment of the current ulceration with urokinase
- need for dialysis
- creatinine > 180µmol/l
- any kind of cerebral event less than three months before inclusion into the study
- proliferative retinopathy (not remediated)
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- uncontrolled hypertension
- hemorrhagic diathesis
- gastrointestinal bleeding
- need for oral anticoagulation
- mental disorders
- pregnancy
- participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum
Dresden, 01307
About this study
Official title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
Read the detailed description
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Being tested
- Urokinase
- Keywords
- urokinase, diabetes, wound healing, major amputation
- Medical subject headings
- Diabetic Foot, Arterial Occlusive Diseases, Ischemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrokinaseDrug
Daily intravenous application of urokinase over 30 minutes
Dosage:
If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interventional group Receives: Drug: Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients being alive, having no major amputation and healed ulceration
Measured: 12 months
Secondary outcomes (1)
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startFeb 2002
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sebastian M. Schellong, Professor, Principal investigator, Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537498
- Sponsor's protocol ID
- MC-UK.2/AVK
- Status last verified
- Sep 2007
- First submitted
- 28 Sep 2007
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
- ClinicalTrials.gov ID
- NCT00537498
- Acronym / sponsor ID
- MC-UK.2/AVK
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Keywords
- urokinase, diabetes, wound healing, major amputation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Oct 2007 (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.
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
Detailed description
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: UrokinaseInterventional group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- angiopathic or angioneuropathic diabetic foot lesions
- critical limb ischemia
- no surgical or interventional treatment option
Key exclusion criteria (13 listed)
- feasibility of vascular surgery or angioplasty
- prior treatment of the current ulceration with urokinase
- need for dialysis
- creatinine > 180µmol/l
- any kind of cerebral event less than three months before inclusion into the study
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 |
|---|---|---|
| UrokinaseDaily intravenous application of urokinase over 30 minutes Dosage: If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l | Drug | 1 |
Primary outcome
Number of patients being alive, having no major amputation and healed ulceration
Time frame: 12 months
1 secondary outcome
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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
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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.
Sebastian M. Schellong, Professor principal investigator
Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Urokinase in people with Diabetic Foot and Arterial Occlusive Disease, run by medac GmbH 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 25 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients being alive, having no major amputation and healed ulceration (time frame: 12 months). 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 25 Mar 2010.