Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Peripheral Neuropathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 26 week, single arm, single siteMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 80 years
- Gender
- Both males and females
Description
This is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for par...
This is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for participants with PAD, diabetic neuropathy and have a clinical diagnosis of type 1 or type 2 diabetes whose main symptoms are numbness and/or tingling of the feet with or without pain. Participants who satisfy eligibility criteria may undergo standard of care revascularization of one lower extremity as required, with the addition of revascularization of the lateral plantar artery and anterior pedal loop followed by a 26-week follow-up phase. Standard of Care revascularization will be performed in any limb with ? 50% stenosis as determined by intra-vascular ultrasound (IVUS) at the time of planned study intervention. Participants will be evaluated prior to intervention and at 2, 4, 14 and 26 weeks after the pedal loop intervention.
Tracking Information
- NCT #
- NCT04720170
- Collaborators
- Modern Vascular, LLC
- Investigators
- Principal Investigator: Dallas Broadway, MD Modern Vascular, LLC Principal Investigator: Mark S Kipnes, MD Diabetes and Glandular Disease Clinic, P.A.