Recruiting

External Compression Therapy

Sponsor:

Temple University

Code:

NCT02054416

Conditions

Critical Limb Ischemia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ArtAssist© Device

Study Details

Brief 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

Study ID

NCT02054416

Start date

Oct, 2013

Status verified date

Oct, 2016

Completion date

Feb, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and Female ages ≥ 21years old
  • Able and willing to provide informed consent
  • Status post amputation of lower limb
  • IPC treatment can be initiated within 30 days post lower limb amputation
  • Ankle-brachial index in the remaining extremity of less than 0.80, or toe- brachial index less than 0 .60 (obtained within last 6 months)
  • Patients must be able to sit and able to perform the compression therapy independently
  • Intact renal function or if patient has chronic kidney disease a pre study Creatinine will be obtained. If the patient has acute renal failure or is a dialysis patient he/she is eligible, but will be separately randomized and analyzed because Creatinine is linked to survival.

  • Subjects status post healed minor (toe/metatarsal) amputations on treatment leg will be included.

Exclusion Criteria:

  • Patients who have no demonstrable peripheral artery disease by ankle-pressure and/or toe-pressure in the remaining limb (initial amputations were mostly precipitated by diabetic neuropathy, deformity, infection, or acute embolization. Amputations resulting from the late effects of trauma, burns, frostbite, etc. are also excluded.
  • Patients who are not able to consent due to their mental status, or who are not willing or able to perform the compression therapy in a sitting position
  • Contracted nursing-home patients with index amputations resulting from largely pressure-related tissue-loss decubitus
  • Patients with infected gangrene or osteomyelitis present in the contra-lateral extremity (which would need to be compressed) at the time of the index amputation
  • Patients with active dry gangrene on the leg that is to be compressed
  • Patients with congestive heart failure
  • Patients in which a deep venous thrombosis or pulmonary embolism is suspected
  • Patients who have undergone arterial compression therapy within 1 year prior to study
  • Bilateral amputation of lower extremity
  • Patients with an expected life-span less than 3 months
  • Patients who require intensive care are not eligible, until they can be transferred to a regular nursing floor
  • Patients in whom the remaining limb is non-functional, for example due to previous stroke

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Art Assist Device

The ArtAssist© (model AA1000) device is made by ACI Medical located in San Marcos, CA (http://acimedical.com/) and is cleared per FDA under K942530.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.

sham comparator: Sham Device

Sham devices look identical to the actual ArtAssist© devices, but provide low-pressure and differ only in number-coded tubing. The study "sham intervention" will consist of one hour of IPC with the sham 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 sham device has an internal device that stores the usage data) to evaluate subject compliance.

Interventions

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.

Primary outcome measure

  • Amputation free survival [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Paul van Bemmelen, MD, PhD

215-707-3622Paul.vanBemmelen@tuhs.temple.edu

Arrikka Mullins, MPH

215-707-7143Arrikka.Mullins@Tuhs.temple.edu

Locations

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Paul van Bemmelen, MD, PhD

215-707-3622paul.vanBemmelen@tuhs.temple.edu

215-707-7143

More Information

Sponsor

Temple University

Last update posted

Nov 8, 2016

Last verified

Oct, 2016

Keywords

  • non-traumatic lower limb amputation
  • AKA
  • BKA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2016-11-08.