- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192242
Investigating a Model for Acute Ischemic Pain in Humans
July 15, 2014 updated by: Philip Lang, Ludwig-Maximilians - University of Munich
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Munich, Germany, 80336
- University Hospital Munich, Pettenkoferstr. 8a
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients over 40 years
- unilateral femoral-popliteal PAD, Fontaine grade II
Exclusion Criteria:
- patients with pain at rest or other pain origin
- diabetic polyneuropathy
- deep vein thrombosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute ischemic pain
acute ischemic pain was induced by treadmill testing in all patients investigated
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acute ischemic pain was induced by treadmill exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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during treadmill exercise (less than 15 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philip M Lang, MD, PhD, Department of Anesthesiology, Ludwig-Maximilians-University Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
July 14, 2014
First Submitted That Met QC Criteria
July 15, 2014
First Posted (Estimate)
July 16, 2014
Study Record Updates
Last Update Posted (Estimate)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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