Status:
UNKNOWN
Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
Lead Sponsor:
Diabetes and Glandular Disease Clinic
Collaborating Sponsors:
Modern Vascular, LLC
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
30-80 years
Phase:
NA
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...
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 reva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04720170
Start Date
February 15 2021
End Date
September 15 2021
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229