RecruitingNot ApplicableNCT05464498

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

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


Sponsor

Guna S.p.a

Enrollment

72 participants

Start Date

Jun 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a collagen-based medical device combined with physiotherapy for treating Achilles tendinopathy — a painful condition caused by damage or degeneration of the Achilles tendon (the large tendon at the back of your heel). The collagen device is injected or applied to the tendon area to support healing, while physiotherapy addresses strength and movement. Together, these treatments aim to reduce pain and restore function faster than physiotherapy alone. You may be eligible if: - You are between 18 and 70 years old - You have had tendon pain for 24 weeks or less - You have been diagnosed with Achilles tendinopathy (insertional, non-insertional, or mystic) confirmed by clinical examination and ultrasound - Your VISA-A score is between 50 and 75 (a scale measuring Achilles tendon function) - Your pain level is 5 or above on a 10-point scale (VAS ≥ 5) You may NOT be eligible if: - You have had previous surgery in the affected area or lower limb - You have already undergone physiotherapy for this condition - You have an autoimmune disease, peripheral nerve disease, or calcific tendinopathy - Your pain is from a direct traumatic injury - You have a local or systemic infection, or cancer - You have gout - You are currently on corticosteroid treatment or used corticosteroids or fluoroquinolone antibiotics in the past 3 months - You used NSAIDs (like ibuprofen) in the past week - You are pregnant or breastfeeding - You are allergic to porcine (pig-derived) collagen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMD-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).

OTHEReccentric 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

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NCT05464498


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