Using Metformin to Treat Chronic Achilles Tendon Pain
Managing Chronic Tendon Pain by Repurposing Metformin
This study is testing if the diabetes drug metformin can help people with chronic Achilles tendon pain feel better and heal faster.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06100822 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral metformin on chronic Achilles tendon pain in non-diabetic patients. It is a randomized, controlled, and blinded study involving 40 participants who will be divided into two groups: one receiving metformin and the other receiving a placebo, both alongside a home exercise program. Over 16 weeks, participants will undergo assessments including functional testing and ultrasound evaluations of the Achilles tendon to measure pain relief and healing. The study aims to provide insights into the potential benefits of metformin for tendon repair.
Who should consider this trial
Good fit: Ideal candidates are non-diabetic individuals diagnosed with chronic Achilles tendinopathy who meet specific pain and tenderness criteria.
Not a fit: Patients with a BMI greater than 30, recent tendon surgery, or systemic inflammatory diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce chronic tendon pain and improve healing for patients suffering from Achilles tendinopathy.
How similar studies have performed: While the use of metformin for tendon pain is a novel approach, similar studies have shown promise in using metabolic agents for tissue repair.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: James H Wang, PhD — University of Pittsburgh
- Study coordinator: James H Wang, PhD
- Email: wanghc@pitt.edu
- Phone: 4126489102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.