Evaluating a new compression system for improving blood flow in the legs
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
This study is testing a new compression system to see if it can improve blood flow in the legs for people who need better circulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Cardinal Health Industry-sponsored |
| Locations | 1 site (Toledo, Ohio) |
| Trial ID | NCT05945186 on ClinicalTrials.gov |
What this trial studies
This study evaluates the hemodynamic performance of the Kendall SCD SmartFlow™ compression system in enhancing blood flow in the legs. Participants will wear Cardinal Health Element compression sleeves while measurements of blood velocity, average mean velocity, and total volume flow in the femoral and popliteal veins will be taken. The goal is to confirm the system's effectiveness in increasing venous blood flow compared to baseline measurements. The study will last approximately 1-2 hours for each participant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 89 with intact legs and normal function who can commit to the study duration.
Not a fit: Patients who are pregnant, breastfeeding, or have certain leg conditions or vascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved blood flow management in patients at risk for venous complications.
How similar studies have performed: While this approach is being evaluated specifically for the Kendall SCD SmartFlow™ system, similar compression technologies have shown promise in enhancing venous blood flow in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be ≥18 years and ≤ 89 years of age. * Subject must be able to speak and read English. * Subject must have both legs fully intact (cannot be an amputee) with normal function. * Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time). * Subject legs must fit into the provided knee length compression sleeves (\<32"). * Subject must give written informed consent. Exclusion Criteria: * Subject is currently pregnant or breastfeeding. * Subject has a positive COVID history within the previous 6 months. * Subject presents with * - local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound * - arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response * - edema of legs or pulmonary edema from congestive heart failure * - deformity of the leg * - current Deep Vein Thrombosis as identified during baseline clinical screening * - recent or old Deep Vein Thrombosis as identified during baseline clinical screening * - reflux in the superficial or deep veins * - history of DVT/PE * - known May-Thurner Syndrome * Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
Where this trial is running
Toledo, Ohio
- Jobst Vascular Institute — Toledo, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Fedor Lurie — Jobst Vascular Institute
- Study coordinator: Victoria Colasanto
- Email: victoria.colasanto@cardinalhealth.com
- Phone: 508-618-3574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.