MedTrace Logo

External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality

NCT02054416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-11-08

No results posted yet for this study

Summary

In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular disease in North Philadelphia.

Patients with cardiovascular disease and recent lower limb amputation will be treated with an intermittent compression device on the remaining lower limb to prevent dual amputation.

The study hypothesis is that the study intervention will protect against further lower limb-loss/death and reduce cardiovascular mortality in these patients (one year effect against limb-loss/death).

This study may result in better secondary prevention strategies for disadvantaged urban populations as well as the general population.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

ArtAssist© Device

The study intervention will consist of one hour of IPC with the ArtAssist© device to the remaining leg, three times a day for a three month period. We will obtain the usage data from the device when the subject returns the device (the device has an internal device that stores the usage data) to evaluate subject compliance.

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Paul van Bemmelen, MD, PhD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-12-31
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054416 on ClinicalTrials.gov