Is NCT06478186 recruiting in Kansas City, KS?

Yes, NCT06478186 is currently recruiting participants at its Kansas City, KS location. This osteoarthritis, knee clinical trial is actively enrolling qualified participants.

How do I join the osteoarthritis, knee clinical trial in Kansas City?

To join this clinical trial in Kansas City, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Kansas City clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Osteoarthritis, Knee Clinical Trial in Kansas City, KS

About This Osteoarthritis, Knee Study in Kansas City

A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period.

Sponsor: University of Kansas Medical Center

Who Can Participate

Inclusion Criteria

1\. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. 3\. Male or female ≥40 years of age. 4. Females with negative pregnancy test, who are not breastfeeding and have no intention to become pregnant during the time from screening through EOS. 5\. Type 2 DM for at least 1 year prior to Screening. 6. Currently being treated with injectable (except insulin) and/or oral antidiabetic agents with stable doses for at least 1 month prior to Screening. 7\. HbA1c 6.5-9% (in past 8 weeks). 8. Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2. (in past 8 weeks) 9. Triglycerides \<500 mg/dL (in past 8 weeks) 10. Painful symptoms associated with OA of the knee for ≥6 months prior to Screening (NRS of 4-9 during most of the 30 days prior to enrollment). 11\. Currently meets modified ACR criteria (clinical and radiological) for OA (Altman et al, 1986) as follows:

At least 1 of the following:

Stiffness \<30 minutes

Osteophytes 12. Index knee pain more than 15 days over the last month (as reported by the subject). 13\. Kellgren-Lawrence Grade 2-4. 14. Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the required time during the study and comply to the correct use requirements of CGM throughout the trial and perform self BG checks as directed. 15\. Adequate BG data collected during the pretreatment phase (Day -10 through Day -1) ≥70% data available.

Exclusion Criteria

Disease-related Criteria

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.

History of infection in the index knee joint.

Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.

Presence of surgical hardware or other foreign body in the index knee.

Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.

Moderate or severe kidney, liver, or thyroid disease.

Active cancer. Previous or Concomitant Treatment-related Criteria

IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening.

IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening.

IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening.

Oral corticosteroids (investigational or marketed) within 1 month of Screening.

Inhaled, intranasal, or topical corticosteroids (investigational or marketed) within 2 weeks of Screening.

Any other IA investigational device, drug/biologic within 6 months of Screening or 5 half-lives (whichever is longer).

Prior arthroscopic or open surgery of the index knee within 12 months of Screening.

Planned/anticipated surgery of the index knee or any other surgery during the study period.

Use of acetaminophen, or acetaminophen-containing products, from Screening through Day 14 (completion of post-treatment BG monitoring).

Subjects on Coumadins with INR ≥5 will be excluded (Bashir et al, 2015) Subject-related Criteria

Known hypersensitivity to any form of triamcinolone.

History of sarcoidosis or amyloidosis.

Active or history of malignancy within the last 3 years, except for resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma.

Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral, or parasitic infections or ocular herpes simplex.

Any infection requiring IV antibiotics within 4 weeks of Screening or infection requiring oral antibiotics within 2 weeks of Screening.

History of osteomyelitis.

Known or clinically suspected infection with human immunodeficiency virus (HIV) or hepatitis B or C viruses.

Requiring or likely to require treatment with corticosteroids during the study period based on subject medical history.

History or active Cushing's or Addison's syndrome.

Active substance abuse (drugs or alcohol), history of chronic substance abuse within the last year, or prior chronic substance abuse judged by the Investigator likely to recur during the study.

Skin breakdown at the knee where the injection would take place.

Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 2 years of Screening.

Receipt of a live or live attenuated vaccine within 3 months of Screening.

Any other clinically significant psychiatric acute or chronic medical conditions that, in the judgment of the Investigator, would preclude the use of an IA corticosteroid or NSAIDs or that could compromise subject safety, limit the subject's ability to complete or adhere to the study, and/or compromise the objectives of the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Kansas City?

Yes, this clinical trial (NCT06478186) has an active research site in Kansas City, KS that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Osteoarthritis, Knee Treatment Options in Kansas City, KS

If you're searching for osteoarthritis, knee treatment options in Kansas City, KS, this clinical trial (NCT06478186) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Kansas City research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced osteoarthritis, knee specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all osteoarthritis, knee clinical trials near you to find additional studies recruiting in your area.

Osteoarthritis, Knee Clinical Trial in Kansas City, KS

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