Status:
RECRUITING
Managing Chronic Tendon Pain by Metformin
Lead Sponsor:
James Wang
Collaborating Sponsors:
United States Department of Defense
Conditions:
Tendinopathy
Chronic Pain
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a blinded and randomized controlled trial that focuses on the treatment effects of metformin (Met) on chronic tendon pain, healing, and repair in midportion Achilles tendinopathy. We will incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06100822
Start Date
May 24 2024
End Date
August 1 2026
Last Update
November 10 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213