Actively Recruiting
Managing Chronic Tendon Pain by Repurposing Metformin in Achilles Tendinopathy
Led by James Wang · Updated on 2026-06-04
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
J
James Wang
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of oral metformin capsules on chronic Achilles tendon pain and tendon healing in non-diabetic adults with this condition. The trial aims to assess how metformin affects tendon pain and repair, compared to placebo, in a randomized and blinded setting involving 40 participants with Achilles tendinopathy. Participants are randomly assigned to one of two groups: one group receives metformin capsules while the other receives placebo capsules, both combined with a home exercise program delivered through a secure online portal. The dosing schedule starts with one capsule daily in week one, increasing weekly up to four capsules daily from weeks 4 to 16. The study includes three visits: screening/baseline, week 4, and week 16. During each visit, participants undergo functional testing, answer questionnaires, and have ultrasound scans of the Achilles tendon to measure various outcomes. Researchers will track changes in tendon pain scores, tendon thickness, tendon structure, and physical function over the 16-week treatment period. The main outcome measure is the change in the VISA-A score, which assesses Achilles tendon symptoms and function.
CONDITIONS
Brief Title
Managing Chronic Tendon Pain by Metformin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent for participation
- Clinical diagnosis of Achilles tendinopathy
- Pain disability index score between 20 and 70 points on the VISA-A scale
- Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture
- Ability to read, speak, and understand English
You will not qualify if you...
- Injection treatment (corticosteroids or orthobiologic) to the targeted tissue within the last 6 months
- Previous Achilles tendon surgery
- Known platelet abnormality or hematological disorder
- Other conditions affecting the functional scale of the indexed limb
- Unwillingness to be randomized
- Body Mass Index greater than 30
- Occult tear in the indexed tendon
- Systemic inflammatory disease
- Use of fluoroquinolone antibiotics in the past 6 months
- Pregnancy, breastfeeding, or planning to become pregnant or breastfeed during the trial
- Chronic kidney disease (eGFR less than 60)
- Diagnosis of diabetes mellitus or elevated HbA1c over 6.5 at screening
- Unable to take oral medication in non-crushable pill form
- Current or recent use of metformin within the last 6 months
- History of allergy to metformin
- History of lactic acidosis or elevated lactate over 2.2 at screening
- Severe hepatic dysfunction
- Currently taking diabetic medications such as sitagliptin, saxagliptin, linagliptin, alogliptin, or sitagliptin with metformin
- Currently taking a carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, or methazolamide
- Currently taking cimetidine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) combining screening and enrollment
Duration - 16 weeks
Participants take daily capsules of either metformin or placebo while following a home exercise program. The dosage increases weekly during the first 3 weeks and continues daily through week 16. Participants complete functional testing and ultrasound assessments during study visits.
3 visits: baseline, Week 4, and Week 16 (in-person)
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
James H Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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