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NCT02192242 Clinical Trial

Investigating a Model for Acute Ischemic Pain in Humans

Peripheral Arterial Disease Clinical Trial

Official title:
Investigating a Model for Acute Ischemic Pain in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02192242
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received July 14, 2014
Last updated July 15, 2014
Start date June 2007
Est. completion date August 2008

Study information
Verified date July 2014
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• acute ischemic pain
acute ischemic pain was induced by treadmill exercise

Locations
Country Name City State
Germany University Hospital Munich, Pettenkoferstr. 8a Munich

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Induce acute ischemic pain To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed. during treadmill exercise (less than 15 minutes) No
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