NCT02192242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

July 14, 2014

Last Update Submit

July 15, 2014

Conditions

Peripheral Arterial Disease

Keywords

acute ischemic painmodelS100interleukine 6

Outcome Measures

Primary Outcomes (1)

  • Induce acute ischemic pain

    To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.

    during treadmill exercise (less than 15 minutes)

Study Arms (1)

Acute ischemic pain

EXPERIMENTAL

acute ischemic pain was induced by treadmill testing in all patients investigated

Other: acute ischemic pain

Interventions

acute ischemic painOTHER

acute ischemic pain was induced by treadmill exercise

Acute ischemic pain

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 40 years
  • unilateral femoral-popliteal PAD, Fontaine grade II

You may not qualify if:

  • patients with pain at rest or other pain origin
  • diabetic polyneuropathy
  • deep vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Munich, Pettenkoferstr. 8a

Munich, 80336, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Philip M Lang, MD, PhD

    Department of Anesthesiology, Ludwig-Maximilians-University Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician, Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

June 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

DE(1)