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Search / Trial NCT06100822

Managing Chronic Tendon Pain by Metformin

Launched by JAMES WANG · Oct 19, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Achilles Tendon Metformin Achilles Tendinopathy Chronic Pain

ClinConnect Summary

This clinical trial is exploring how well metformin, a medication commonly used to treat diabetes, can help manage chronic pain in the Achilles tendon. The study involves two groups of participants: one group will receive metformin capsules for 16 weeks, while the other group will receive a placebo (a pill with no active medication) along with a home exercise program. The goal is to see if metformin can reduce tendon pain and promote healing in patients who have been diagnosed with Achilles tendinopathy, a condition that causes pain and discomfort in the tendon at the back of the ankle.

To be eligible for this trial, participants should be between 18 and 62 years old, able to understand English, and have a clinical diagnosis of Achilles tendinopathy with a specific level of pain. They should not have had recent treatments for the condition, previous surgeries on the Achilles tendon, or certain health issues that could affect their participation. Those who join the study can expect to take the assigned medication for 16 weeks, keep up with a guided exercise program, and attend follow-up appointments to monitor their progress. This trial is currently seeking volunteers, so if you or someone you know is struggling with chronic Achilles tendon pain, this could be an opportunity to explore a new treatment option.

Gender

ALL

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

About James Wang

James Wang is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the healthcare sector, Mr. Wang focuses on innovative therapeutic solutions that address unmet medical needs. His leadership emphasizes collaboration with research institutions and regulatory bodies to ensure rigorous study design, ethical standards, and adherence to best practices. By fostering a culture of transparency and accountability, James Wang aims to contribute significantly to the development of safe and effective treatments across various therapeutic areas.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

James H Wang, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported