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

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04720170
• Other study ID #: DBMK-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2021
• Source: Diabetes and Glandular Disease Clinic
• Contact: Terri L Ryan, RN
• Phone: 210-614-8612
• Email: terri.ryan[@]dgdclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Diabetes and Glandular Disease Clinic, P.A.	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes and Glandular Disease Clinic	Modern Vascular, LLC

Country where clinical trial is conducted

United States, 

References & 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.2 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ram Z, Sadeh M, Walden R, Adar R. Vascular insufficiency quantitatively aggravates diabetic neuropathy. Arch Neurol. 1991 Dec;48(12):1239-42. — View Citation

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.15 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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

External Links

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