Comparative Physiologic Technology Study

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT01126788
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study is designed to test two hypotheses:

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-23
• Last Update Posted: 2010-11-24
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Massachsetts General Hospital; 🇺🇸 Boston, Massachusetts, United States