Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Knee pain
Stiffness <30 minutes
Crepitus
Disqualifiers
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.
Trial design
Treatments tested in this trial
- triamcinolone acetonide extended-release injectable suspension; TCA-ER
- Triamcinolone Acetonide- Immediate Release;TCA-IR
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov