Type 2 Diabetes MellitusAugust-1NCT01599442
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
An observational study of Type 2 Diabetes Mellitus and Diabetic Foot, run by GWT-TUD GmbH at 1 site in Germany.
Trial summary
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Foot, Critical Limb Ischemia
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Jul 2013
- Phase
- Observational
- 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
Study population: outpatients from hospitals with a department specializing in the treatment of diabetic foot syndrome
Who may be able to join
- diabetic patients with dfs and critical limb ischemia
- age 18 and older
Who cannot join
- less than 1 year life expectancy
- prior major amputation
- planned major expectation
- prior treatment of the current episode of dfs with urokinase
- mechanical heart valve replacement
- cerebral event with changes in CT during the last three months
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- non-remediated proliferating retinopathy
- uncontrolled hypertension (systolic > 180 mmHg, diastolic > 100 mmHg)
- hemorrhagic diathesis (spontaneous quick value < 50%, spontaneous ptt > 40 sec, thrombocytes < 100 gpt/l)
- acute gastrointestinal bleeding or ulcers during the last 4 weeks
- prior reverse bypass operation
- concomitant participation in other clinical trials
- insufficient compliance
- premenopausal women not using a safe method of contraception (i. e. IUD, hormone implants, hormone depot injection, combined pill (estrogens and gestagens), vaginal ring or vasectomized partner).
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. Results from clinical trials about the efficacy of interventions aimed at reducing the number of patient-relevant end points are of limited comparability due to the heterogenity of patient characteristics. By their very nature, randomized clinical trials (RCT) can only focus on a limited section of the wide range of possible intervention regimes. In clinical practice, however, a number of patients with dfs will never have been part of a clinical trial. Furthermore, there are only very few contemporary registers for this indication from which conclusions with regard to the comparative merits of different therapeutic strategies may be drawn.
The register was conceived to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.
Read the detailed description
August-1 is a register to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot, Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of survival without major amputation
Measured: to be assessed after 12 months observation
Secondary outcomes (2)
major amputation
Measured: after 12 months observation
total mortality
Measured: after 12 months observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJun 2010
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: recrution number was not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Schellong, Prof.Dr.med., Principal investigator, Staedt. KH Dresden-Friedrichstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599442
- Sponsor's protocol ID
- August-1
- Acronym
- August-1
- Status last verified
- Apr 2014
- First submitted
- 14 May 2012
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01599442
- Acronym / sponsor ID
- August-1 / August-1
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recrution number was not reached
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 May 2012 (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.
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. Results from clinical trials about the efficacy of interventions aimed at reducing the number of patient-relevant end points are of limited comparability due to the heterogenity of patient characteristics. By their very nature, randomized clinical trials (RCT) can only focus on a limited section of the wide range of possible intervention regimes. In clinical practice, however, a number of patients with dfs will never have been part of a clinical trial. Furthermore, there are only very few contemporary registers for this indication from which conclusions with regard to the comparative merits of different therapeutic strategies may be drawn.
The register was conceived to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.
Detailed description
August-1 is a register to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients from hospitals with a department specializing in the treatment of diabetic foot syndrome
Key inclusion criteria (2 listed)
- diabetic patients with dfs and critical limb ischemia
- age 18 and older
Key exclusion criteria (14 listed)
- less than 1 year life expectancy
- prior major amputation
- planned major expectation
- prior treatment of the current episode of dfs with urokinase
- mechanical heart valve replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration of survival without major amputation
Time frame: to be assessed after 12 months observation
2 secondary outcomes
major amputation
Time frame: after 12 months observation
total mortality
Time frame: after 12 months observation
Results and safety
The study was stopped early (reason given: recrution number was not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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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.
S. Schellong, Prof.Dr.med. principal investigator
Staedt. KH Dresden-Friedrichstadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Diabetic Foot, run by GWT-TUD 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 2 inclusion and 14 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 7 Apr 2014. 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.
Are results available for this study?
The study was stopped early (reason given: recrution number was not reached). 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?
duration of survival without major amputation (time frame: to be assessed after 12 months observation). 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 7 Apr 2014.