Peripheral Arterial DiseaseNCT02192242
Investigating a Model for Acute Ischemic Pain in Humans
A study testing acute ischemic pain in people with Peripheral Arterial Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The pathophysiology of acute ischemic pain is not well established. The aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- acute ischemic pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Aug 2008
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 40 years
- unilateral femoral-popliteal PAD, Fontaine grade II
Who cannot join
- patients with pain at rest or other pain origin
- diabetic polyneuropathy
- deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
The pathophysiology of acute ischemic pain is not well established. The aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.
- Conditions
- Peripheral Arterial Disease
- Being tested
- acute ischemic pain
- Keywords
- acute ischemic pain, model, S100, interleukine 6
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute ischemic painOther
acute ischemic pain was induced by treadmill exercise
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic pain | Experimental | acute ischemic pain was induced by treadmill testing in all patients investigated Receives: Other: acute ischemic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induce acute ischemic pain
To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.
Measured: during treadmill exercise (less than 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Lang, Ludwig-Maximilians - University of Munich
- Investigators
- Philip M Lang, MD, PhD, Principal investigator, Department of Anesthesiology, Ludwig-Maximilians-University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192242
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Model for Acute Ischemic Pain in Humans
- ClinicalTrials.gov ID
- NCT02192242
- Acronym / sponsor ID
- 001
- Conditions
- Peripheral Arterial Disease
- Keywords
- acute ischemic pain, model, S100, interleukine 6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Jul 2014 (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 pathophysiology of acute ischemic pain is not well established. The aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic pain | Experimental | Other: acute ischemic painacute ischemic pain was induced by treadmill testing in all patients investigated |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 40 years
- unilateral femoral-popliteal PAD, Fontaine grade II
Key exclusion criteria (3 listed)
- patients with pain at rest or other pain origin
- diabetic polyneuropathy
- deep vein thrombosis
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 |
|---|---|---|
| acute ischemic painacute ischemic pain was induced by treadmill exercise | Other | Acute ischemic pain |
Primary outcome
Induce acute ischemic pain
Time frame: during treadmill exercise (less than 15 minutes)
To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.
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 16 Jul 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.
Philip M Lang, MD, PhD principal investigator
Department of Anesthesiology, Ludwig-Maximilians-University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acute ischemic pain in people with Peripheral Arterial Disease, run by Ludwig-Maximilians - University of Munich 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 3 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 16 Jul 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 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?
Induce acute ischemic pain (time frame: during treadmill exercise (less than 15 minutes)). 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 16 Jul 2014.