Diabetic FootPhase 3NCT00823225
Urokinase Therapy in Patients With Diabetic Foot Syndrome
A Phase 3 study testing standard therapy and Urokinase in people with Diabetic Foot and Arterial Occlusive Disease, run by medac GmbH at 6 sites in Germany.
Trial summary
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival. 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?
- standard therapy and Urokinase
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 3
- 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
- Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
- No surgical or interventional treatment option
- No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
- Fibrinogen > 4.0 g/l
- No previous major amputation
Who cannot join
- Prior treatment of the current ulceration with urokinase
- Need for dialysis and/or creatinine-clearance < 20ml/min
- INR > 1,5 at screening
- Any kind of cerebral event within 3 months prior inclusion
- Proliferative retinopathy
- Uncontrolled hypertension
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- Hemorraghic diathesis
- Gastrointestinal bleeding
- Pregnancy
- No compliance and/or participation in another trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Franziskus Krankenhaus
Berlin
Klinikum Dortmund Nord GmbH
Dortmund
Krankenhaus Dresden-Neustadt
Dresden
Universitätsklinik
Dresden
Weißeritztal-Kliniken GmbH
Freital
Klinikum Karlsbad Langensteinbach
Karlsbad
About this study
Official title: Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
Read the detailed description
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Being tested
- standard therapy, Urokinase
- Keywords
- Diabetes, urokinase, ulcer healing, major amputation, survival
- 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.
standard therapyProcedure or surgery
wound debridement, moist wound dressing
UrokinaseDrug
Daily infusion up to 21 applications, dose dependent on fibrinogen level:
> 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU
| Study group | Role | What they receive |
|---|---|---|
| A: Standard therapy | Other | Not described Receives: Procedure: standard therapy |
| B: Urokinase | Experimental | Not described Receives: Drug: Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major amputation free survival
Measured: Within twelve months after randomisation
Secondary outcomes (1)
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Measured: Within twelve month after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Insufficient recruitment of study patients
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sebastian Schellong, MD, Principal investigator, Krankenhaus Dresden-Friedrichstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823225
- Sponsor's protocol ID
- MC-UK.3/AVK
- Other IDs
- EudraCT number 2007-005916-15
- Status last verified
- Mar 2015
- First submitted
- 14 Jan 2009
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
- ClinicalTrials.gov ID
- NCT00823225
- Acronym / sponsor ID
- MC-UK.3/AVK
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Keywords
- Diabetes, urokinase, ulcer healing, major amputation, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment of study patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Jan 2009 (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 determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
Detailed description
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Standard therapy | Other | Procedure: standard therapy |
| B: Urokinase | Experimental | Drug: Urokinase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
- No surgical or interventional treatment option
- No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
- Fibrinogen > 4.0 g/l
- No previous major amputation
Key exclusion criteria (10 listed)
- Prior treatment of the current ulceration with urokinase
- Need for dialysis and/or creatinine-clearance < 20ml/min
- INR > 1,5 at screening
- Any kind of cerebral event within 3 months prior inclusion
- Proliferative retinopathy
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 |
|---|---|---|
| standard therapywound debridement, moist wound dressing | Procedure or surgery | A: Standard therapy |
| UrokinaseDaily infusion up to 21 applications, dose dependent on fibrinogen level: > 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU | Drug | B: Urokinase |
Primary outcome
Major amputation free survival
Time frame: Within twelve months after randomisation
1 secondary outcome
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Time frame: Within twelve month after randomisation
Results and safety
The study was stopped early (reason given: Insufficient recruitment of study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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
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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 Schellong, MD principal investigator
Krankenhaus Dresden-Friedrichstadt, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard therapy and Urokinase in people with Diabetic Foot and Arterial Occlusive Disease, run by medac GmbH at 6 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Insufficient recruitment of study patients). Results are not available in the source record.
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?
Major amputation free survival (time frame: Within twelve months after randomisation). 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 13 Mar 2015.