Investigating a Model for Acute Ischemic Pain in Humans | NCT02192242

Studies
Investigating a Model for Acute Ischemic Pain in Humans

NCT02192242

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

acute ischemic pain

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philip Lang, Attending physician, Assistant Professor of Anesthesiology, Ludwig-Maximilians - University of MunichPrincipal Investigator

Lead Sponsor

Ludwig-Maximilians - University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute ischemic pain	Experimental	acute ischemic pain was induced by treadmill testing in all patients investigated	Other: acute ischemic pain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acute ischemic pain	Other	acute ischemic pain was induced by treadmill exercise	Acute ischemic pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Induce acute ischemic pain	To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.	during treadmill exercise (less than 15 minutes)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip M Lang, MD, PhD	Department of Anesthesiology, Ludwig-Maximilians-University Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Munich, Pettenkoferstr. 8a		Munich		80336	Germany

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided