Back to resultsInvestigating a Model for Acute Ischemic Pain in Humans
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
acute ischemic pain
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring acute ischemic pain, model, S100, interleukine 6
Eligibility Criteria
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
Sites / Locations
- University Hospital Munich, Pettenkoferstr. 8a
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acute ischemic pain
Arm Description
acute ischemic pain was induced by treadmill testing in all patients investigated
Outcomes
Primary Outcome Measures
Induce acute ischemic pain
To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.
Secondary Outcome Measures
Full Information
NCT ID
NCT02192242
First Posted
July 14, 2014
Last Updated
July 15, 2014
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02192242
Brief Title
Investigating a Model for Acute Ischemic Pain in Humans
Official Title
Investigating a Model for Acute Ischemic Pain in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
acute ischemic pain, model, S100, interleukine 6
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute ischemic pain
Arm Type
Experimental
Arm Description
acute ischemic pain was induced by treadmill testing in all patients investigated
Intervention Type
Other
Intervention Name(s)
acute ischemic pain
Intervention Description
acute ischemic pain was induced by treadmill exercise
Primary Outcome Measure Information:
Title
Induce acute ischemic pain
Description
To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.
Time Frame
during treadmill exercise (less than 15 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M Lang, MD, PhD
Organizational Affiliation
Department of Anesthesiology, Ludwig-Maximilians-University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Munich, Pettenkoferstr. 8a
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
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Investigating a Model for Acute Ischemic Pain in Humans
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