Treatment for Achilles Tendinopathy with Collagen and Physiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a porcine collagen-based medical device, MD-Tissue, combined with physiotherapy in treating Achilles tendinopathy. Participants will be randomly assigned to receive either the collagen treatment alongside an eccentric strengthening physiotherapy protocol or physiotherapy alone. The study aims to assess pain reduction and functional improvement over an 8-week period through various evaluations at multiple time points. The trial focuses on individuals with clinically diagnosed Achilles tendinopathy, aiming to provide a more effective treatment option.

Why it matters

Who can join: the full rules

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.

Where it's running

• U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°"
  Roma, Ro, Italy Recruiting

Study contacts

• Principal investigator: Paoloni PM Marco, Prof — U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma
• Study coordinator: Miranda MV Vincenzo, Dr
• Email: v.miranda@guna.it
• Phone: 3351311917

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.