The Mito-PPND Study seeks to assess the safety and effectiveness of a combination of over-the-counter supplements for reducing painful peripheral neuropathy
About this study
Peripheral neuropathy is particularly prevalent in older patients with long-standing diabetes, or those with suboptimal blood sugar control. Pain is the most disturbing symptom of diabetic peripheral neuropathy, as it can be severe or even debilitating, and can lead to significant disability and impact on quality of life. This research project is testing a new treatment for painful diabetic peripheral neuropathy. We aim to study if these supplements are successful in reducing nerve pain in people with type 2 diabetes and to assess whether their mobility and quality of life also improves.
Anticipated enrolment close date: 15 September 2025
Who can take part
Inclusion criteria
This trial might be right for you if the following apply:
- Type 2 diabetes
- Aged greater than 18 years
- Diagnosis of diabetes-related painful peripheral neuropathy
Exclusion from the study
- active foot ulcer and/or infection
- poor kidney function
- clinical diagnosis of chronic liver disease
- bleeding disorders or use of oral anticoagulant medications
- women who are lactating, pregnant or intend to become pregnant during the course of the study
- cancer treated in the 12 months prior
- the occurrence of any acute bacterial infection or diarrhoea within the 4 weeks prior to starting in this study
What's involved
- You will be asked to take a combination of over-the-counter supplements daily over 16 weeks.
- There are 3 visits in total. Visit 1 (Week 0) and Visit 3 (Week 16) will be at the Royal Melbourne Hospital and we will call you via telehealth for Visit 2 (Week 8) to see how you are progressing in the study.
- The onsite visits will take about 2 to 3 hours, and the telehealth call about 30 minutes of your time.
- The onsite visits will involve a blood sample, the recording of clinical measures such as weight, blood pressure, assessment of pain intensity, and you will be asked to completed some questionnaire surveys.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.