Actively Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Led by Guna S.p.a · Updated on 2025-08-03
72
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 70 years
- Tendon pain lasting 24 weeks or less
- Clinically diagnosed and ultrasonographically confirmed insertional, noninsertional, or mystic Achilles tendinopathy
- VISA-A score between 50 and 75
- Pain score (VAS) of 5 or higher
- Ability to understand and answer the SF12 questionnaire
- Ability to understand and sign the informed consent
You will not qualify if you...
- Previous surgery in the investigated area or lower extremity
- Prior physiotherapy treatment
- Autoimmune diseases
- Peripheral neuropathy
- Calcific tendinopathy
- Pain caused by direct trauma
- Local or systemic infections
- Neoplastic diseases
- Gout
- Current corticosteroid treatment
- Use of corticosteroids or fluoroquinolones in the past three months
- Use of NSAIDs in the week before enrollment
- Pregnancy or breastfeeding
- Contraindications to acetaminophen
- Allergy to porcine collagen
AI-Screening
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Trial Site Locations
Total: 1 location
1
U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°"
Roma, RO, Italy, 00185
Actively Recruiting
Research Team
M
Miranda MV Vincenzo, Dr
CONTACT
L
Laarej Kamilia, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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