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New treatment option for Tendinopathy
Official title Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
ClinicalTrials.gov ID: NCT05464498
What this study is testing
- What it's testing
- Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male and female people aged 18 to 70 years;
- people with tendon pain for not more than 24 weeks;
- people with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy;
- people with a VISA A score between 50 and 75;
- VAS ≥ 5;
You likely can't join if
- people who have had surgery in the investigated area or lower extremity;
- people who have previously undergone physiotherapy.
- people with autoimmune diseases;
- people with peripheral neuropathy;
- people with calcific tendinopathy
- people with pain of direct traumatic origin;
See the full eligibility criteria
- Male and female people aged 18 to 70 years;
- people with tendon pain for not more than 24 weeks;
- people with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy;
- people with a VISA A score between 50 and 75;
- VAS ≥ 5;
- people able to understand and answer the SF12 questionnaire;
- people able to understand and sign the informed consent.
- people who have had surgery in the investigated area or lower extremity;
- people who have previously undergone physiotherapy.
- people with autoimmune diseases;
- people with peripheral neuropathy;
- people with calcific tendinopathy
- people with pain of direct traumatic origin;
- people with local/systemic infections;
- people with neoplastic diseases;
- people with gout;
- people on corticosteroid treatment at the time of enrollment;
- people who have used corticosteroids or fluoroquinolones in the three months prior to enrollment;
- people who have used NSAIDs in the week prior to enrollment;
- people who are pregnant and lactating;
- people with contraindications to acetaminophen use;
- allergy to porcine collagen.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.