Diabetic Peripheral Neuropathy
Conditions
Keywords
Diabetes, Type 1 Diabetes, Type 2 Diabetes, Neuropathy, Diabetic Peripheral Neuropathy, Peripheral Artery Disease, PAD
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.
Interventions
PROCEDURERevascularization
Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
Sponsors
Modern Vascular, LLC
Diabetes and Glandular Disease Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
26 week, single arm, single site
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Sudoscan | 14 and 26 weeks | Number and percentage of participants with 20% improvement on Sudoscan |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactTerri L Ryan, RN
Backup ContactJosette M Negrete, BAAS
Outcome results
None listed