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

Diabetic Peripheral Neuropathy Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT04720170
• Study type: Interventional
• Source: Diabetes and Glandular Disease Clinic
• Contact: Terri L Ryan, RN
• Phone: 210-614-8612
• Email: terri.ryan@dgdclinic.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2021
• Completion date: September 15, 2021