Managing Chronic Tendon Pain by Metformin

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
James Wang
Study ID
NCT06100822
Phase
PHASE1
Status
Recruiting
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Conditions

  • Achilles Tendinopathy
  • Chronic Pain
  • Tendinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    500 mg capsules of Metformin Extended Release
  • Placebo — DRUG
    500 mg capsules of placebo pills

Study Details

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.

Key Dates

Start date
May 24, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group, Placebo Capsules
    Placebo 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
  • Experimental: Treatment Group, Metformin Capsules
    Treatment 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

Primary Outcome Measure

Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score [ Time Frame: baseline, 4 weeks, 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Jessica Eldridge
[email protected]

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By research site
University of Pittsburgh· Pittsburgh, PA

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