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Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy

NCT07028528•RDC Clinical Pty Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged 18-75 years.
•Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).
•Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
•Able to provide informed consent.
•Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
•Agree to not participate in another clinical trial during the study period.
•Able to attend an ACL collection centre.

Exclusion Criteria

•Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection \[HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy\]; autoimmune disease \[Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome\]; trauma / injury; toxins \[heavy metals, chemicals\]; antibiotics; or inflammatory conditions \[vasculitis\]).
•Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease
•Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia
•Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
•Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
•Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa).
•Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
•Chronic past and/or current alcohol use (\>14 alcoholic drinks per week)
•Females attempting to conceive, pregnant or lactating
•Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula.
+3 more criteria

Locations (1)

RDC Clinical

Fortitude Valley, Queensland, Australia

Key Dates

Start Date

July 1, 2025

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

July 23, 2025

Enrollment

ESTIMATED participants

Conditions

Diabetic Peripheral Neuropathy

Interventions

Levagen+

DIETARY_SUPPLEMENT

Placebo

OTHER

Contacts

Amanda Rao

CONTACT

+61(0)731024486 research@rdcglobal.com.au

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

Inclusion Criteria

Exclusion Criteria

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