External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | February 2019 |
| Contact: | Paul van Bemmelen, MD, PhD |
| Email: | Paul.vanBemmelen@tuhs.temple.edu |
| Phone: | 215-707-3622 |
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality in Underserved Philadelphia Patient Population: A Randomized Controlled Study
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.
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.
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.
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.
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
We found this trial at
1
site
3401 N Broad St
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania
(215) 707-2000
Phone: 215-707-3622
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
Click here to add this to my saved trials
