The purpose of the current exploratory clinical trial is to determine the effect of oral ingestion of metformin (OIM) in non-diabetic patients with chronic Achilles tendon pain. The trial has two aims; 1) to assess the effects of OIM treatment on tendon pain, and 2) to determine the effects of OIM capsules on tendon healing and repair. Twenty participants will be treated with metformin capsules for 16 weeks combined with a home exercise program. A comparison group of 20 participants will be treated with placebo tablets along with home exercise program.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide informed consent for participation
* Clinical diagnosis of Achilles tendinopathy
* Pain disability index score of between 20 - 70 points (0-100 scale VISA-A)
* Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture.
* Ability to read, speak, and understand English
Exclusion Criteria:
* Any intervention (corticosteroids or other orthobiologic intervention as injection) to targeted tissue within the last 6 months.
* Previous Achilles tendon surgery.
* Known platelet abnormality or hematological disorder.
* Presence of other conditions that might affect the functional scale of the indexed limb.
* Unwillingness to be randomized.
* Body Mass Index (BMI) greater than 30.
* Occult tear in the indexed tendon.
* Systemic inflammatory disease.
* Use of fluoroquinolone in the past 6 months.
* Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
* Chronic kidney disease (eGFR \<60)
* Diagnosis of diabetes mellitus or elevated HbA1c at screening (\> 6.5)
* Unable to take an oral medication in a non crushable pill form
* Taking metformin presently or within the last 6 months
* History of allergy to metformin
* History of lactic acidosis or elevated lactate at screening (\> 2.2)
* Severe Hepatic dysfunction
* Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
* Cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score