NCT04720170

Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity

Revascularization of the Lateral Plantar Artery and Anterior Pedal Loop of the Foot as Treatment for Diabetic Peripheral Neuropathy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Diabetes and Glandular Disease Clinic · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate 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 diabetic peripheral neuropathy.

Detailed 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 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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
PROCEDURE	Revascularization	Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-07-15
• Completion: 2021-09-15
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States