Long-Term Follow-up of the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis

Conditions
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Tendinosis, Tendinopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in a clinical trial designed to evaluate RCT-01 treatment for chronic Achilles tendinosis. Participants must complete the final study visit in the earlier trial prior to participation in this clinical trial. Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol. Exclusion Criteria: The presence of any condition that, in the investigator's opinion would impact participant safety and/or a participant's ability to complete all study related procedures. (e.g., psychiatric illness, drug addiction, alcoholism, etc.) NOTE: age limits not specifically set in this trial as entry into current trial based on qualification/completion of previous clinical trial where age rage of participants was explicitly stated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RCT-01<br>Participants in previous clinical trial that received blinded injection of RCT-01 | |
| Placebo<br>Participants in previous clinical trial that received blinded injection of placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Comparison of the safety profile between RCT-01/placebo treatment groups. The safety profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events. | 24 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire | pain on palpation and pain on loading (running/jumping) | 24 months post-injection | 
| Modified Tegner Activity Scale |  | 24 months post-injection | 
| SF-36 questionnaire | quality of life questionnaire | 24 months post-injection | 
| Tendon condition (appearance) | Ultrasound imaging will be utilized to measure region and relative location (from calcaneus) of damage and overall tendon size (in mm) | 24 months post-injection | 
| Tendon condition (blood flow) | Ultrasound imaging will be utilized to measure blood flow (vascularization) within the tendon. Defined on ordinal scale | 24 months post-injection | 
| Tendon condition (fibrillar pattern) | Fibrillar pattern observed during ultrasound imaging of tendon structure will be graded on ordinal scale. | 24 months post-injection | 
| Tendon condition (presence of abnormalities) | Presence/absence of intratentinous calcification, observable tears, and irregularities in calcaneus bone structure will be noted during ultrasound imaging. | 24 months post-injection |