Managing Chronic Tendon Pain by Metformin
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedNovember 10, 2025
November 1, 2025
1.9 years
October 9, 2023
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
The VISA-A is a self-administered questionnaire that asks about Achilles tendon pain, function, and activity. Scores range from 0 to 100 with a low score indicating more severe pain.
baseline, 4 weeks, 16 weeks
Secondary Outcomes (11)
Change in VAS score
baseline, 4 weeks, 16 weeks
Change in tendon thickness
baseline, 4 weeks, 16 weeks
Change in tendon cross-sectional area
baseline, 4 weeks, 16 weeks
Change in tendon neovascularization
baseline, 4 weeks, 16 weeks
Change in tendon hypoechogenicity
baseline, 4 weeks, 16 weeks
- +6 more secondary outcomes
Study Arms (2)
Placebo Group, Placebo Capsules
PLACEBO COMPARATORPlacebo Group (n=20) Week 1: One placebo capsule (500 mg) daily Week 2: Two placebo capsules (1,000 mg) daily Week 3: Three placebo capsules (1,500 mg) daily Week 4-16: Four placebo capsules (2,000 mg) daily
Treatment Group, Metformin Capsules
EXPERIMENTALTreatment Group (n=20) Week 1: One metformin ER capsule (500 mg) daily Week 2: Two metformin (ER) capsules (1,000 mg) daily Week 3: Three metformin (ER) capsules (1,500 mg) daily Week 4-16: Four metformin (ER) capsules (2,000 mg) daily
Interventions
Eligibility Criteria
You may qualify 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 may not qualify 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 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- James Wanglead
- United States Department of Defensecollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James H Wang, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 9, 2023
First Posted
October 25, 2023
Study Start
May 24, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement. For more information or to submit a request, please contact wanghc@pitt.edu
Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.