Clinical trial NCT04720170: Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
Official title: Revascularization of the Lateral Plantar Artery and Anterior Pedal Loop of the Foot as Treatment for Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes
Type 1 Diabetes
Type 2 Diabetes
Neuropathy
Diabetic Peripheral Neuropathy
Peripheral Artery Disease
PAD
Lead sponsor: Diabetes and Glandular Disease Clinic
Sponsor class: INDUSTRY
Collaborators: name: Modern Vascular, LLC
First posted: 2021-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 26 week, single arm, single site
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 30 to 80 years (inclusive at first screening visit)
2. Clinical diagnosis of type 1 or type 2 diabetes as diagnosed by HbA1c ≥ 6.5% or current treatment
3. 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)
4. HbA1c ≤ 11% (historical results allowed if performed within the past 90 days)
5. Females of child-bearing potential who are willing to use contraceptive measures to prevent pregnancy for the duration of the study
6. Willing to attend all scheduled study visits and undergo all study procedures
7. Clinical diagnosis of Peripheral Artery Disease (PAD)
8. Be able to understand, speak, read and write English
9. Have medical insurance or financial means to cover the cost of the revascularization procedure and follow-up visits with the Interventional Radiologist

Exclusion Criteria:

1. Inability to undergo angiogram with revascularization
2. Unilateral neuropathic findings or symptoms
3. Vitamin B-12 level \< 400 pg/ml (historical results allowed if performed within the past 30 days) \*
4. 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
5. Known history of Hepatitis B, C, or HIV
6. Lower limb amputation, including toe
7. Lower extremity inoperable occlusive vascular disease
8. Inability to provide informed consent
9. History of bleeding disorders
10. History of diabetic ulcers to the lower extremities
11. History of any surgical bypass of the lower extremities prior to randomization
12. History of previous revascularization of the lower extremities prior to randomization
13. End Stage Renal Disease (ESRD) requiring or on dialysis
14. Thyroid Stimulating Hormone -TSH \>10.0 uu/mL\*
15. Potassium \> 5.5 mmol/L. \*
16. Calcium \< 8.5 mg/dL or \> 11mg/dL \*
17. Hemoglobin \< 9.0 g/dL \*
18. Female that is pregnant, breastfeeding or intends to become pregnant during the study period
19. Clinically significant abnormal ECG findings, in the opinion of the Investigator
20. Participation in another clinical trial with investigational drug or device at time of screening
21. 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

Primary outcomes:
measure: Intra-epidermal Nerve Fiber Density
timeFrame: 26 weeks
Secondary outcomes:
measure: Intra-epidermal Nerve Fiber Density
timeFrame: 14 and 26 weeks
measure: Utah Early Neuropathy Scale
timeFrame: 14 and 26 weeks
measure: Sural Nerve Action Potential Amplitude
timeFrame: 14 and 26 weeks
measure: Sudoscan
timeFrame: 14 and 26 weeks
measure: Intra-epidermal Nerve Fiber Density
timeFrame: 14 weeks
measure: Neuropathic Pain Syndrome Inventory
timeFrame: 14 and 26 weeks
measure: Patency of Lateral Plantar Artery
timeFrame: 14 and 26 weeks
Other outcomes:
measure: Medial Plantar Sural Nerve Action Potential Amplitude
timeFrame: 14 and 26 weeks
Locations:
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic, P.A.
state: Texas
Study officials:
affiliation: Modern Vascular, LLC
name: Dallas Broadway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes and Glandular Disease Clinic, P.A.
name: Mark S Kipnes, MD
role: PRINCIPAL_INVESTIGATOR
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