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RECRUITING
NCT05464498
NA

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

Sponsor: Guna S.p.a

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2022-06-13

Completion Date

2026-01-13

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DEVICE

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).

OTHER

eccentric strengthening protocol

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

Locations (1)

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

Roma, RO, Italy