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

January 20, 2021 updated by: Diabetes and Glandular Disease Clinic

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Clinic, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-epidermal Nerve Fiber Density
Time Frame: 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.
26 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes and Glandular Disease Clinic

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2021

Primary Completion (ANTICIPATED)

July 15, 2021

Study Completion (ANTICIPATED)

September 15, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBMK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and Informed Consent

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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