Treatment for Achilles Tendinopathy with Collagen and Physiotherapy

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.

This study tests if a new collagen treatment combined with physiotherapy can help people with Achilles tendinopathy feel less pain and move better compared to just physiotherapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guna S.p.a (Industry-sponsored)
• Locations: 1 site (Roma, RO)
• Trial ID: NCT05464498 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 70 with tendon pain lasting no more than 24 weeks and a VISA A score between 50 and 75.

Not a fit: Patients who have had prior surgery in the affected area or have undergone physiotherapy previously may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve function for patients suffering from Achilles tendinopathy.

How similar studies have performed: While the use of collagen-based treatments is gaining interest, this specific combination of collagen injection and physiotherapy is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Roma, RO

• 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

Conditions Tendinopathy; Insertional Achilles Tendinopathy; Achilles Tendinopathy; Peritendinitis; Eccentric strengthening; Collagene Medical Device; Physiotherapy; Peritendinous area