Study of Porcine Collagen Medical Device with Physiotherapy for Achilles Tendinopathy Pain and Function Improvement

What this Trial Is About

Achilles tendinopathy is an inflammatory condition of the Achilles tendon, which can be classified into insertional tendinitis affecting the lower tendon near the heel bone, and noninsertional tendinitis that affects the middle tendon fibers, often seen in young, athletic, and middle-aged individuals. This research aims to study the effects of a porcine collagen-based medical device combined with physiotherapy on reducing pain and improving tendon function. The study is a multicenter, randomized clinical investigation lasting 8 weeks. Participants will be randomized into two groups Group A will receive both physiotherapy using an eccentric strengthening protocol and injections of the MD-Tissue Collagen Medical Device around the tendon, delivered as six peri-tendon injections over three weeks. Group B will receive only the physiotherapy program, which includes Achilles tendon stretching exercises conducted over 6 weeks. The trial evaluates how this combined approach compares to physiotherapy alone. Throughout the study, participants will undergo assessments at baseline, weekly up to week 3, at week 6, and at weeks 8 and beyond. These evaluations include the VISA-A questionnaire to assess tendon health, pain intensity measurements using the Visual Analogue Scale, physical and mental health surveys, tracking of analgesic drug use, and monitoring for adverse events. The main outcome is the VISA-A score at week 8, reflecting both pain and function improvements.

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