Actively Recruiting
Managing Chronic Tendon Pain by Metformin
Led by James Wang · Updated on 2025-11-10
40
Participants Needed
1
Research Sites
114 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
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.
CONDITIONS
Official 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 a 0-100 scale (VISA-A)
- Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture
- Ability to read, speak, and understand English
You will not qualify if you...
- Any corticosteroid or orthobiologic injection to the targeted tissue within the last 6 months
- Previous Achilles tendon surgery
- Known platelet abnormality or hematological disorder
- Presence of other conditions affecting 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 antibiotics in the past 6 months
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Chronic kidney disease with eGFR less than 60
- Diagnosis of diabetes mellitus or elevated HbA1c above 6.5 at screening
- Unable to take oral medication in non-crushable pill form
- Taking metformin currently or within the last 6 months
- History of allergy to metformin
- History of lactic acidosis or elevated lactate above 2.2 at screening
- Severe hepatic dysfunction
- Currently taking diabetic medications such as sitagliptin, saxagliptin, linagliptin, alogliptin, or sitagliptin with metformin
- Currently taking carbonic anhydrase inhibitors such as topiramate, zonisamide, acetazolamide, dichlorphenamide, or methazolamide
- Currently taking cimetidine
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
James H Wang, PhD
CONTACT
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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