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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Critical Limb Ischemia

In brief

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.

Key facts

Study ID

NCT02054416

Run by

Temple University

People needed

120

Starts

2013-10-01

Expected to finish

2019-02-01

Last updated by the study team

2016-11-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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