NCT01126788

Brief Summary

This study is designed to test two hypotheses:

  1. 1.The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab testing system in a group of patients referred for evaluation of PAD of the limbs when performed by a Registered Vascular Technologist (RVT).
  2. 2.The PADnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the PADnet+ system but are not vascular technologists nor hold the RVT certification.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 24, 2010

Status Verified

November 1, 2010

Enrollment Period

2 years

First QC Date

May 18, 2010

Last Update Submit

November 23, 2010

Conditions

Peripheral Arterial Disease

Study Arms (2)

PADnet + testing

Parks Flo-lab Test

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred to the MGH Vascular Labs for diagnostic testing for PAD

You may qualify if:

  • All patients referred to the MGH Vascular Labs for diagnostic testing for PAD

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachsetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Glenn LaMuraglia, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 20, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 24, 2010

Record last verified: 2010-11

Locations

US(1)