Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
NCT ID: NCT04720170
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-02-15
2021-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression
NCT00703209
Reversing Diabetic Peripheral Neuropathy Through Exercise
NCT03686423
Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy
NCT07100301
A Pilot Study of the Effectiveness of Foot-Ankle and Walking Exercises in Patients With Diabetes Mellitus
NCT07270328
Exercise Induced Hypoalgesia Diabetes
NCT05296642
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Revascularization
Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Revascularization
Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Modern Vascular, LLC
UNKNOWN
Diabetes and Glandular Disease Clinic
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dallas Broadway, MD
Role: PRINCIPAL_INVESTIGATOR
Modern Vascular, LLC
Mark S Kipnes, MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes and Glandular Disease Clinic, P.A.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
PubMed ID:11719828
PubMed ID:10382594
PubMed ID:2376302
PubMed ID:3094772
PubMed ID:8307254
PubMed ID:8721781
PubMed ID:1478366
PubMed ID:8591818
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DBMK-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.