NCT06100822 · James Wang
Managing Chronic Tendon Pain by Metformin
What this study is about
The purpose of the current exploratory clinical trial is to determine the effect of taken by mouth 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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
- Currently taking cimetidine
Where
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations