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

NCT02054416 | Unknown DMC

• 1 other identifier: PVB012013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

non-traumatic lower limb amputation; AKA; BKA

Outcome Measures

Primary Outcomes (1)

• Amputation free survival

  1 year

Study Arms (2)

Art Assist Device

ACTIVE COMPARATOR

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.

Device: ArtAssist© Device

Sham Device

SHAM COMPARATOR

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.

Device: ArtAssist© Device

Interventions

ArtAssist© Device 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.

Also known as: The ArtAssist© (model AA1000)

Art Assist Device; Sham Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Paul van Bemmelen, MD, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul van Bemmelen, MD, PhD

CONTACT

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

Arrikka Mullins, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: November 8, 2016

Record last verified: 2016-10

Locations

US (1)