NCT05464498 Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
| NCT ID | NCT05464498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guna S.p.a |
| Condition | Tendinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2024-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2022-06-13 with a primary completion date of 2024-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Paoloni PM Marco, Prof
PRINCIPAL INVESTIGATOR
U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma
Frequently Asked Questions
Who can join the NCT05464498 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Tendinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05464498 currently recruiting?
Yes, NCT05464498 is actively recruiting participants. Contact the research team at v.miranda@guna.it for enrollment information.
Where is the NCT05464498 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05464498 clinical trial?
NCT05464498 is sponsored by Guna S.p.a. The principal investigator is Paoloni PM Marco, Prof at U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma. The trial plans to enroll 72 participants.