Intermittent Pneumatic Compression Device Assessment in Patients with Severe Arterial and Venous Disease of the Lower Extremity
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-005393
Sponsor Protocol Number: 13-005393
About this study
The purpose of this study is to determine whether a specific external compression pump called the AVT pump can improve blood flow to the skin of the feet in patients with circulatory problems involving the arteries or veins of the legs. The use of the AVT pump in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Vascular Laboratory test results including ankle-brachial indices (ABI) less than 0.7 and/or transcutaneous oxygen tension (TcPO2) values < 40 mm Hg or > 40 mm Hg with a 10 mm Hg drop upon elevation at 45 degrees for 10 minutes. Patients with non-compressible vessels (ABI values > 1.4) may be enrolled by meeting the TcPO2 requirement only.
- Patients not meeting vascular laboratory criteria for inclusion.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Robert McBane, M.D.
Closed for enrollment
Publications are currently not available