Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

Launched by GUNA S.P.A · Jul 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with Achilles tendinopathy, which is a painful condition affecting the Achilles tendon at the back of the ankle. The researchers want to see if using a special collagen-based medical device, combined with physiotherapy, can help reduce pain and improve function in the tendon. This trial is particularly important because there are currently no strong guidelines on how to effectively treat this condition, and the goal is to find a better approach.

To be eligible for the study, participants must be between 18 and 70 years old and have been experiencing tendon pain for no more than 24 weeks. They should have a specific score indicating the level of their pain and be able to understand and complete a questionnaire about their health. However, certain people, such as those who have had surgery in the area, have autoimmune diseases, or are currently taking specific medications, will not be able to participate. If you join the trial, you can expect to receive the collagen treatment along with physiotherapy sessions, and you will be monitored for improvements in pain and function over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects aged 18 to 70 years;
• • Subjects with tendon pain for not more than 24 weeks;
• • Subjects with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy;
• • Subjects with a VISA A score between 50 and 75;
• • VAS ≥ 5;
• • Subjects able to understand and answer the SF12 questionnaire;
• • Subjects able to understand and sign the informed consent.
• Exclusion Criteria:
• • subjects who have had surgery in the investigated area or lower extremity;
• • subjects who have previously undergone physiotherapy.
• • subjects with autoimmune diseases;
• • subjects with peripheral neuropathy;
• • subjects with calcific tendinopathy
• • subjects with pain of direct traumatic origin;
• • subjects with local/systemic infections;
• • subjects with neoplastic diseases;
• • subjects with gout;
• • subjects on corticosteroid treatment at the time of enrollment;
• • subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment;
• • subjects who have used NSAIDs in the week prior to enrollment;
• • subjects who are pregnant and lactating;
• • subjects with contraindications to acetaminophen use;
• • allergy to porcine collagen.