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Tests treatment safety and results for Diabetic Peripheral Neuropathy
Official title Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07028528
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic...
- Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
- Difficulty swallowing capsules.
- Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Fortitude Valley, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortitude Valley, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.