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

Primary Purpose

Critical Limb Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ArtAssist© Device

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring non-traumatic lower limb amputation, AKA, BKA

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Temple University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Art Assist Device

Sham Device

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Amputation free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02054416

First Posted

January 31, 2014

Last Updated

November 4, 2016

Sponsor

Temple University

1. Study Identification

Unique Protocol Identification Number

NCT02054416

Brief Title

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

Acronym

ArtAssist

Official Title

External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality in Underserved Philadelphia Patient Population: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The purpose of this study is to evaluate whether a non-invasive intervention for 3 months with an intermittent compression device (ArtAssist®) in a high risk patient group reduces the risk of subsequent one-year limb-loss and/or death (e.g. one-year amputation-free survival and overall survival.) Survival after an amputation is markedly decreased due to generalized cardiovascular disease. The thirty-day mortality after amputation ranges from 6% to 16% depending on renal function. Two-year mortality after amputation is up to 40%.For dialysis patients, two year mortality was 58%.13 The five-year mortality after amputation in non-renal patients is 65%, while in dialysis patients five-year mortality is 83%. Patients who have undergone a major lower extremity amputation related to vascular disease are also at increased risk for losing their remaining lower extremity. The loss of the second lower extremity has a more profound impact on patients' ability to ambulate or function independently than the first amputation. Despite intensive initial rehabilitation, the use of prosthetics in bilateral amputees decreases rapidly over time. Contra-lateral amputations occur in up to 33%, after a mean of eight months. According to another study, 17% of diabetic initial amputees become bilateral amputees after a median time of less than one year for men and less than two years for women. According to a 2013 study, the majority of the subsequent contra-lateral amputations occur in the first year after the index amputation. We hope to prove that that there is a role for IPC in vascular patients at high-risk for mortality and limb-loss with relatively low-cost compression therapy. We hope to learn more about which underserved patient categories are most likely to benefit from this and when to start the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Limb Ischemia

Keywords

non-traumatic lower limb amputation, AKA, BKA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Art Assist Device

Arm Type

Active Comparator

Arm Description

Arm Title

Sham Device

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

ArtAssist© Device

Other Intervention Name(s)

The ArtAssist© (model AA1000)

Intervention Description

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 Information:

Title

Amputation free survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul van Bemmelen, MD, PhD

Phone

215-707-3622

Paul.vanBemmelen@tuhs.temple.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Arrikka Mullins, MPH

Phone

215-707-7143

Arrikka.Mullins@Tuhs.temple.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul van Bemmelen, MD, PhD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul van Bemmelen, MD, PhD

Phone

215-707-3622

paul.vanBemmelen@tuhs.temple.edu

Phone

215-707-7143

12. IPD Sharing Statement

Learn more about this trial

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

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