Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
NCT ID:
NCT02054416
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02054416
Study Brief:
Protocol Section:
NCT02054416