NCT06100822 Managing Chronic Tendon Pain by Metformin
| NCT ID | NCT06100822 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | James Wang |
| Condition | Tendinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-05-24 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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; 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.
Eligibility 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
Contact & Investigator
James H Wang, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06100822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Tendinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06100822 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06100822 currently recruiting?
Yes, NCT06100822 is actively recruiting participants. Contact the research team at wanghc@pitt.edu for enrollment information.
Where is the NCT06100822 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06100822 clinical trial?
NCT06100822 is sponsored by James Wang. The principal investigator is James H Wang, PhD at University of Pittsburgh. The trial plans to enroll 40 participants.