NCT01014377
Completed
Not Applicable
Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia
VascuActive LTD1 site in 1 country15 target enrollmentNovember 2009
ConditionsPeripheral Vascular Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- VascuActive LTD
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Pain-free and Maximal walking distance
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
- •Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
- •ABI \< 0.7 by Doppler, in at least one of the two foot arteries
Exclusion Criteria
- •Absent femoral pulses
- •Venous insufficiency by Duplex
- •Pregnancy
- •Infectious disease
- •Malignant disease
- •Severe cardiac disease, e.g., CHF grade 3 or higher
- •Acute MI within last 3 months
- •CABG within last 3 months
- •Other severe systemic disease
Outcomes
Primary Outcomes
Pain-free and Maximal walking distance
Time Frame: 1 hour
Secondary Outcomes
- Skin temperature(1 hour)
- Skin blood flow(1 hour)
- Transcutaneous partial pressure of O2 and CO2(1 hour)
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)Breast CancerNCT06125522Pfizer11
Unknown
Not Applicable
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral NeuropathyDiabetic Neuropathy, PainfulNCT01214590VascuActive LTD15
Completed
Not Applicable
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc DiseaseDegenerative Disc DiseaseNCT00589797Aesculap Implant Systems376
Completed
Not Applicable
Safety & Feasibility Study of Tack-It Device for Vessel Dissection RepairCritical Limb IschemiaPeripheral Artery DiseaseNCT02044003Philips Clinical & Medical Affairs Global11
Completed
Not Applicable
A Study of Patients With Dry Mouth and Sticky Saliva During RadiotherapyXerostomiaNCT02687087NHS Greater Glasgow and Clyde44