Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
NCT06100822

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

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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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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