Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects Wit… (NCT05464498) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Italy72 participantsStarted 2022-06-13
Plain-language summary
Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Insertional tendinitis involves the lower part of the tendon, where the tendon inserts at the level of the calcaneus, and can affect even patients who are not particularly athletically active. Noninsertional tendinitis occurs when the fibers in the middle portion of the tendon are affected, affects young and athletic people the most, and has a high incidence (30-50%) in middle-aged individuals.
Considering that there are no strong evidence-based guidelines in the area of treatment of achilles tendinopathy, the aim of this research project is to understand through a multicenter, randomized clinical investigation the impact of treatment with a porcine collagen-based medical device administered in the peri-tendon area in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon.