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

Sponsor

Diabetes and Glandular Disease Clinic (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04720170

Collaborator

Modern Vascular, LLC (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	Procedure: Revascularization	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

26 week, single arm, single site26 week, single arm, single site

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Jul 15, 2021

Anticipated Study Completion Date :

Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm 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.

Arm

Intervention/Treatment

Other: Single Arm

Procedure: Revascularization

Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.

Outcome Measures

Primary Outcome Measures

Intra-epidermal Nerve Fiber Density [26 weeks]
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.

Secondary Outcome Measures

Intra-epidermal Nerve Fiber Density [14 and 26 weeks]
Number and percent of participants whose IENFD have increased by at least 20% from baseline
Utah Early Neuropathy Scale [14 and 26 weeks]
Number and percentage of participants with improvement on Utah Neuropathy Scale (UENS)
Sural Nerve Action Potential Amplitude [14 and 26 weeks]
Number and percentage of participants with improvement of sural nerve action potential amplitude
Sudoscan [14 and 26 weeks]
Number and percentage of participants with 20% improvement on Sudoscan
Intra-epidermal Nerve Fiber Density [14 weeks]
Number and percentage of participants with improvement of intra-epidermal nerve fiber density
Neuropathic Pain Syndrome Inventory [14 and 26 weeks]
Improvement in quality of life as measured by the Neuropathic Pain Syndrome Inventory
Patency of Lateral Plantar Artery [14 and 26 weeks]
Number and percentage of participants with patency of lateral plantar artery per ultrasound

Other Outcome Measures

Medial Plantar Sural Nerve Action Potential Amplitude [14 and 26 weeks]
Number of participants with 20% change in medial plantar sural nerve action potential amplitude (SNAP) via nerve conduction study

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female age 30 to 80 years (inclusive at first screening visit)
Clinical diagnosis of type 1 or type 2 diabetes as diagnosed by HbA1c ≥ 6.5% or current treatment
Clinical signs and symptoms of diabetic peripheral neuropathy bilaterally affecting the lower extremities, in the investigator's opinion, which may include neuropathic symptoms (e.g., numbness, tingling, burning sensation, sharp pains, sensitivity to touch) and decreased distal sensation (e.g., decreased vibration, pinprick or pain sensation, monofilament)
HbA1c ≤ 11% (historical results allowed if performed within the past 90 days)
Females of child-bearing potential who are willing to use contraceptive measures to prevent pregnancy for the duration of the study
Willing to attend all scheduled study visits and undergo all study procedures
Clinical diagnosis of Peripheral Artery Disease (PAD)
Be able to understand, speak, read and write English
Have medical insurance or financial means to cover the cost of the revascularization procedure and follow-up visits with the Interventional Radiologist

Exclusion Criteria:

Inability to undergo angiogram with revascularization
Unilateral neuropathic findings or symptoms
Vitamin B-12 level < 400 pg/ml (historical results allowed if performed within the past 30 days) *
Known causes of peripheral neuropathy other than diabetes, e.g., Amyloidosis, Tangier disease, Fabry's disease, hereditary sensory autonomic neuropathy, alcohol-related neuropathy, drug-induced neuropathy (e.g., chemotherapy, antibiotics, anti-retroviral agents, other neurotoxic agents) hypothyroidism that is not well controlled, rheumatoid arthritis or autoimmune disorders requiring treatment with corticosteroids, anti-tumor necrosis factor or immune-modulating medicines
Known history of Hepatitis B, C, or HIV
Lower limb amputation, including toe
Lower extremity inoperable occlusive vascular disease
Inability to provide informed consent
History of bleeding disorders
History of diabetic ulcers to the lower extremities
History of any surgical bypass of the lower extremities prior to randomization
History of previous revascularization of the lower extremities prior to randomization
End Stage Renal Disease (ESRD) requiring or on dialysis
Thyroid Stimulating Hormone -TSH >10.0 uu/mL*
Potassium > 5.5 mmol/L. *
Calcium < 8.5 mg/dL or > 11mg/dL *
Hemoglobin < 9.0 g/dL *
Female that is pregnant, breastfeeding or intends to become pregnant during the study period
Clinically significant abnormal ECG findings, in the opinion of the Investigator
Participation in another clinical trial with investigational drug or device at time of screening
Any other clinically significant disorders or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the protocol requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes and Glandular Disease Clinic, P.A.	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Diabetes and Glandular Disease Clinic
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.