Intermittent Mechanical Compression For Peripheral Arteri... | NCT00855673

Studies
Intermittent Mechanical Compression For Peripheral Arterial Disease

NCT00855673

Sponsor

Hospital Universitario Getafe

Status

Completed

Last Update Posted

Mar 4, 2009Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Peripheral Arterial Disease

Interventions

Intermittent Mechanical Compression
Control

Countries

Not provided

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

Feb 2009

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

Jan 2001

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Mar 2, 2009

First Submission Date that Met QC Criteria

Mar 2, 2009

First Posted Date

Mar 4, 2009Estimated

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

Mar 2, 2009

Last Update Posted Date

Mar 4, 2009Estimated

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 study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease.

Major endpoints are improved exercise tolerance and relevant blood pressure ratios

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Active group receiving intermittent compression	Device: Intermittent Mechanical Compression
Control	Active Comparator	Standard Medical Treatment	Drug: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intermittent Mechanical Compression	Device	FM220 device	Active
Control

Measure	Description	Time Frame
exercise tolerance		3 months

Measure	Description	Time Frame
ankle-brachial index		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stable claudication with an absolute claudication distance >40 meters but <300
resting ABI in the affected limb <0.8

Exclusion Criteria:

presence of diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joaquin DeHaro, MD	Hospital Universitario Getafe	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease
D007383	Intermittent Claudication

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided