Actively Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy Multicenter Randomized Clinical Investigation; AKITENMED STUDY
Led by Guna S.p.a · Updated on 2025-08-03
72
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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 no more than 24 weeks
- Clinically diagnosed and confirmed insertional, noninsertional, or mystic Achilles tendinopathy
- VISA-A score between 50 and 75
- Visual Analogue Scale pain score of 5 or higher
- Ability to understand and answer the SF12 questionnaire
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior surgery in the investigated area or lower extremity
- Previous physiotherapy for the affected tendon
- 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 last three months
- Use of NSAIDs in the week before enrollment
- Pregnancy or breastfeeding
- Contraindications to acetaminophen
- Allergy to porcine collagen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive treatment with a collagen-based medical device combined with physiotherapy or physiotherapy alone, focusing on eccentric strengthening exercises for the Achilles tendon.
6 physiotherapy sessions with 6 peri-tendon injections for participants in the device group (2 injections per week for 3 weeks)
Duration - 2 weeks
Participants are assessed for pain reduction and functional improvement at several time points after treatment using questionnaires and pain scales.
Visits at weeks 6 and 8 after enrollment
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
L
Laarej Kamilia, Dr
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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