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Clinical Trials in Italy / NCT05464498
Recruiting Not applicable

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

NCT05464498 · tracked via the Priya Life Science Italy tracker
Sponsor
Guna S.p.a
Phase
Not applicable
Started
2022-06-13
Last updated
2026-09-11

Condition(s) studied

TendinopathyInsertional Achilles TendinopathyAchilles TendinopathyPeritendinitis

Investigational drug(s) / intervention(s)

MD-Tissue Collagen Medical Deviceeccentric strengthening protocol

MD-Tissue Collagen Medical Device: MD-Tissue (GUNA, Milan-Italy) Composition per 2 ml: collagen 100 micrograms Excipients: Ascorbic acid, Magnesium gluconate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, NaCl, Water for injection. Subjects will be treated with No. 6 peri-tendon injections (2 infiltrations per week for three weeks).

eccentric strengthening protocol: Group B which, will implement only physiotherapy (eccentric strengthening protocol)

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon. — Weeks 8
    The primary end point will be assessed at week 8 and will involve: Assessment of the VISA-A questionnaire score at time weeks 8 compared to day 0. A difference between the two groups of 12 out of 100 points on the questionnaire can be considered clinically significant. We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon.

Trial sites (1)

FacilityCityRegionStatus
U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Roma RO Recruiting

More Guna S.p.a trials in Italy

Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05464498 on ClinicalTrials.gov ↗ ← All trials in Italy