Tendinopathy Clinical Trial
Official title:
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
The primary purpose of this study is to assess the long-term safety profile of RCT-01
injections as compared to placebo injections. This study will also measure the long-term
impact these injections will have on tendon structure and function and the symptoms of
Achilles tendinosis.
This is study is designed to follow participants who have completed participation in a
clinical trial where they received injections of either RCT-01 or placebo in the Achilles
tendon. No clinical interventions will be performed as part of study procedures.
The day of study entry (Visit 1) will be coordinated with the participant's final visit in
the earlier clinical trial. All participants will return to the clinic for repeat
assessments of their Achilles tendinosis and overall health 6, 12 and 18 months after study
entry. Furthermore, they will complete 'telephone visits'; during which they will report
information on their overall health; 3, 9, and 15 months after study entry. Total duration
of patient participation is approximately 18 months.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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