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New treatment option for Tendinopathy
Official title Managing Chronic Tendon Pain by Metformin
ClinicalTrials.gov ID: NCT06100822
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tendinopathy.
Also referred to as Glucophage, Glucophage XR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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
You likely can't join if
- 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 assigned by chance.
- Body Mass Index (BMI) greater than 30.
See the full eligibility 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
- 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 assigned by chance.
- Body Mass Index (BMI) greater than 30.
- Occult tear in the indexed tendon.
- Systemic inflammatory disease.
- Use of fluoroquinolone in the past 6 months.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.