An interventional study of Revascularization in Diabetic Peripheral Neuropathy, sponsored by Diabetes and Glandular Disease Clinic. Status unknown at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Diabetes and Glandular Disease Clinic · Not applicable, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Diabetes and Glandular Disease Clinic is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Procedure: Revascularization
Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
Intra-epidermal Nerve Fiber Density
Change from baseline in intra-epidermal nerve fiber density (IENFD) via skin biopsy of the revascularized foot over the extensor digitorum brevis muscle (EDBM) at week 26.
Time frame: 26 weeks
Intra-epidermal Nerve Fiber Density
Number and percent of participants whose IENFD have increased by at least 20% from baseline
Time frame: 14 and 26 weeks
Utah Early Neuropathy Scale
Number and percentage of participants with improvement on Utah Neuropathy Scale (UENS)
Time frame: 14 and 26 weeks
Sural Nerve Action Potential Amplitude
Number and percentage of participants with improvement of sural nerve action potential amplitude
Time frame: 14 and 26 weeks
Sudoscan
Number and percentage of participants with 20% improvement on Sudoscan
Time frame: 14 and 26 weeks
Intra-epidermal Nerve Fiber Density
Number and percentage of participants with improvement of intra-epidermal nerve fiber density
Time frame: 14 weeks
Neuropathic Pain Syndrome Inventory
Improvement in quality of life as measured by the Neuropathic Pain Syndrome Inventory
Time frame: 14 and 26 weeks
Patency of Lateral Plantar Artery
Number and percentage of participants with patency of lateral plantar artery per ultrasound
Time frame: 14 and 26 weeks
Medial Plantar Sural Nerve Action Potential Amplitude
Number of participants with 20% change in medial plantar sural nerve action potential amplitude (SNAP) via nerve conduction study
Time frame: 14 and 26 weeks
Plan to share: Yes — Study protocol and Informed Consent
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Diabetes and Glandular Disease Clinic