NCT04720170

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 20, 2021

Last Update Submit

January 20, 2021

Conditions

Diabetic Peripheral Neuropathy

Keywords

DiabetesType 1 DiabetesType 2 DiabetesNeuropathyDiabetic Peripheral NeuropathyPeripheral Artery DiseasePAD

Outcome Measures

Primary Outcomes (1)

  • Intra-epidermal Nerve Fiber Density

    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 Outcomes (7)

  • Intra-epidermal Nerve Fiber Density

    14 and 26 weeks

  • Utah Early Neuropathy Scale

    14 and 26 weeks

  • Sural Nerve Action Potential Amplitude

    14 and 26 weeks

  • Sudoscan

    14 and 26 weeks

  • Intra-epidermal Nerve Fiber Density

    14 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Medial Plantar Sural Nerve Action Potential Amplitude

    14 and 26 weeks

Study Arms (1)

Single Arm

OTHER

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

Interventions

RevascularizationPROCEDURE

Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.

Single Arm

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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. \*
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Related Publications (11)

  • Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.

    PMID: 15030944RESULT

  • Cameron NE, Eaton SE, Cotter MA, Tesfaye S. Vascular factors and metabolic interactions in the pathogenesis of diabetic neuropathy. Diabetologia. 2001 Nov;44(11):1973-88. doi: 10.1007/s001250100001.

    PMID: 11719828RESULT

  • Ibrahim S, Harris ND, Radatz M, Selmi F, Rajbhandari S, Brady L, Jakubowski J, Ward JD. A new minimally invasive technique to show nerve ischaemia in diabetic neuropathy. Diabetologia. 1999 Jun;42(6):737-42. doi: 10.1007/s001250051222.

    PMID: 10382594RESULT

  • Malik RA, Masson EA, Sharma AK, Lye RH, Ah-See AK, Compton AM, Tomlinson DR, Hanley SP, Boulton AJ. Hypoxic neuropathy: relevance to human diabetic neuropathy. Diabetologia. 1990 May;33(5):311-8. doi: 10.1007/BF00403326.

    PMID: 2376302RESULT

  • Newrick PG, Wilson AJ, Jakubowski J, Boulton AJ, Ward JD. Sural nerve oxygen tension in diabetes. Br Med J (Clin Res Ed). 1986 Oct 25;293(6554):1053-4. doi: 10.1136/bmj.293.6554.1053.

    PMID: 3094772RESULT

  • Ram Z, Sadeh M, Walden R, Adar R. Vascular insufficiency quantitatively aggravates diabetic neuropathy. Arch Neurol. 1991 Dec;48(12):1239-42. doi: 10.1001/archneur.1991.00530240043016.

    PMID: 1845025RESULT

  • Singleton JR, Bixby B, Russell JW, Feldman EL, Peltier A, Goldstein J, Howard J, Smith AG. The Utah Early Neuropathy Scale: a sensitive clinical scale for early sensory predominant neuropathy. J Peripher Nerv Syst. 2008 Sep;13(3):218-27. doi: 10.1111/j.1529-8027.2008.00180.x.

    PMID: 18844788RESULT

  • Tesfaye S, Harris N, Jakubowski JJ, Mody C, Wilson RM, Rennie IG, Ward JD. Impaired blood flow and arterio-venous shunting in human diabetic neuropathy: a novel technique of nerve photography and fluorescein angiography. Diabetologia. 1993 Dec;36(12):1266-74. doi: 10.1007/BF00400804.

    PMID: 8307254RESULT

  • Veves A, Donaghue VM, Sarnow MR, Giurini JM, Campbell DR, LoGerfo FW. The impact of reversal of hypoxia by revascularization on the peripheral nerve function of diabetic patients. Diabetologia. 1996 Mar;39(3):344-8. doi: 10.1007/BF00418351.

    PMID: 8721781RESULT

  • Young MJ, Veves A, Walker MG, Boulton AJ. Correlations between nerve function and tissue oxygenation in diabetic patients: further clues to the aetiology of diabetic neuropathy? Diabetologia. 1992 Dec;35(12):1146-50. doi: 10.1007/BF00401368.

    PMID: 1478366RESULT

  • Young MJ, Veves A, Smith JV, Walker MG, Boulton AJ. Restoring lower limb blood flow improves conduction velocity in diabetic patients. Diabetologia. 1995 Sep;38(9):1051-4. doi: 10.1007/BF00402174.

    PMID: 8591818RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Dallas Broadway, MD

    Modern Vascular, LLC

    PRINCIPAL INVESTIGATOR

  • Mark S Kipnes, MD

    Diabetes and Glandular Disease Clinic, P.A.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri L Ryan, RN

CONTACT

210-614-8612terri.ryan@dgdclinic.com

Josette M Negrete, BAAS

CONTACT

210-614-8612josette.negrete@dgdclinic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 26 week, single arm, single site
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

February 15, 2021

Primary Completion

July 15, 2021

Study Completion

September 15, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Study protocol and Informed Consent

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Starting 6 months after publication

Locations

US(1)