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

Status unconfirmed · Not applicable

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT04720170

Run by

Diabetes and Glandular Disease Clinic

People needed

30

Starts

2021-02-15

Expected to finish

2021-09-15

Last updated by the study team

2021-01-22

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Diabetes and Glandular Disease Clinic, P.A. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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