TendinopathyAKITENMEDNCT05464498
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
A study testing MD-Tissue Collagen Medical Device and eccentric strengthening protocol in people with Tendinopathy and Insertional Achilles Tendinopathy, run by Guna S.p.a at 1 site in Italy.
Trial summary
Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendinopathy, Insertional Achilles Tendinopathy, Achilles Tendinopathy
- What is being tested?
- MD-Tissue Collagen Medical Device and eccentric strengthening protocol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2022to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 70 years;
- Subjects with tendon pain for not more than 24 weeks;
- Subjects with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy;
- Subjects with a VISA A score between 50 and 75;
- VAS ≥ 5;
- Subjects able to understand and answer the SF12 questionnaire;
- Subjects able to understand and sign the informed consent.
Who cannot join
- subjects who have had surgery in the investigated area or lower extremity;
- subjects who have previously undergone physiotherapy.
- subjects with autoimmune diseases;
- subjects with peripheral neuropathy;
- subjects with calcific tendinopathy
- subjects with pain of direct traumatic origin;
Show all 15Show fewer
- subjects with local/systemic infections;
- subjects with neoplastic diseases;
- subjects with gout;
- subjects on corticosteroid treatment at the time of enrollment;
- subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment;
- subjects who have used NSAIDs in the week prior to enrollment;
- subjects who are pregnant and lactating;
- subjects with contraindications to acetaminophen use;
- allergy to porcine collagen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°"
Roma, RO, 00185
Paoloni PM Marco, Prof., 3498434651 ext. +39, marco.paoloni@uniroma1.it
About this study
Official title: Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.
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.
Read the detailed description
In view of the morpho-structural changes that characterize Achilles tendinopathy, the use of injectable medical devices such as Collagen Medical Devices might find therapeutic indication. For some years now, in fact, the use of injectable medical devices based on porcine collagen and ancillary substances of natural origin (Collagen Medical Devices GUNA) has been introduced in the treatment of painful and degenerative pathologies of the locomotor system, which allow a more effective and specific placement of collagen in situ with the function of vehiculation and stabilization.
The purpose of this research project is to understand through a multicenter, randomized clinical study investigation the impact of treatment with a porcine Collagen-based Medical Device called MD-Tissue, administered in the peri-tendon area, in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.
The multicenter, randomized clinical investigation is prospective, and will have a total duration of 8 weeks.
After enrollment, subjects will be randomized and assigned to two experimental groups:
- Group A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device.
- Group B which, will implement only physiotherapy (eccentric strengthening protocol).
Variables will be assessed at baseline (T0 time), after 1 week (T1), after 2 weeks (T2), after 3 weeks (T3), at the end of the injection treatment, and 6 weeks after enrollment (T6/FU). A further evaluation will be carried out after 2 weeks and after 8 weeks T8/FU from the start of the investigation study.
After enrollment, subjects in both groups will begin a physiotherapy course (eccentric strengthening protocol), lasting 6 weeks. Each session will consist of stretching exercises of the Achilles tendon.
- Being tested
- MD-Tissue Collagen Medical Device, eccentric strengthening protocol
- Keywords
- Eccentric strengthening, Collagene Medical Device, Physiotherapy, Peritendinous area, Infiltration, Type I collagen, Eccentric strengthening protocol, Pain Visual Analog Scale, 12-Item Short Form Survey, Victorian Institute of Sport Assessment- Achilles questionnaire
- Medical subject headings
- Tendinopathy, Tenosynovitis, Osteogenesis Imperfecta, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-Tissue Collagen Medical DeviceDevice
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).
eccentric strengthening protocolOther
Group B which, will implement only physiotherapy (eccentric strengthening protocol)
| Study group | Role | What they receive |
|---|---|---|
| MD-Tissue Medical Device | Experimental | Group A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device. Receives: Device: MD-Tissue Collagen Medical Device; Other: eccentric strengthening protocol |
| Eccentric strengthening protocol | Other | Group B who will only perform physiotherapy (eccentric strengthening protocol). Receives: Other: eccentric strengthening protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon.
The primary end point will be assessed at week 8 and will involve: Assessment of the VISA-A questionnaire score at time weeks 8 compared to day 0. A difference between the two groups of 12 out of 100 points on the questionnaire can be considered clinically significant.
We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon.
Measured: Weeks 8
Secondary outcomes (6)
Assessment of the VISA-A (Victorian Institute of Sport Assessment- Achilles) questionnaire score at T3 and T6 weeks, ranging from 0 to 100 points, where 100 points represents a healthy tendon.
Evaluation of VISA-A score at time weeks 3 and weeks 6 compared to day 0. We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon
Measured: Weeks 3, weeks 6.
Assessment of the VAS (Visual Analogue Scale) at time weeks 3, weeks 6 and weeks 8, allows the patient to define pain intensity along a line from 0 to 10 cm (100 mm).
Assessment of the VAS (Visual Analogue Scale) at time weeks 3, weeks 6 and weeks 8 compared to day 0.
Visual Analogue Scale (VAS) allows the patient to define pain intensity along a line from 0 to 10 cm (100 mm). One end indicates no pain 'no pain' while the other represents maximum pain 'maximum pain'.
Measured: Weeks 3, weeks 6, weeks 8
Evaluation of the SF12 (Item Short Form Survey) questionnaire at times weeks 3, weeks 6 and weeks 8 determinated the phisical condition and mental healthy functioning.
Evaluation of the SF12 (Item Short Form Survey) questionnaire at time weeks 3, weeks 6 and weeks 8 compared to day 0.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning A score of 50 or less o has been recommended as a cut-off to determine a physical condition; while a score of 42 or less may be indicative of 'clinical depression.
The questionnaire needs to be supported by a statistical programme for further analysis.
Measured: Weeks 3, weeks 6 and weeks 8.
Evaluation of the fraction of subjects in each group achieving Minimal Clinical Disease (MCD) considering that the MCD of the VISA-A questionnaire is 18.5 (90% MCD).
Evaluation of the fraction of subjects in each group achieving Minimal Clinical Disease (MCD) considering that the MCD of the VISA-A questionnaire is 18.5 (90% MCD), after treatment and study duration.
Measured: Day 0, week 1, weeks 2,weeks 3, weeks 6 and weeks 8.
Assessment of analgesic drug unit consumption based on clinical diary
Assessment of analgesic drug unit consumption based on clinical diary at time weeks 3, weeks 6 and weeks 8, (paracetamol 1000 mg. will be used as "rescue dose" in case of onset/recurrence of pain).
Measured: Weeks 3,weeks 6 and weeks 8.
Evaluation of the fraction of subjects in each group who drop out early in relation to Adverse Events (AE/SAE/SUSAR)
Evaluation of the fraction of subjects in each group who drop out early in relation to Adverse Events (AE/SAE/SUSAR
Measured: Day 0, week 1,weeks 2,weeks 3,weeks 6 and weeks 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start13 Jun 2022
- Primary completion13 Feb 2024
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guna S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paoloni PM Marco, Prof, Principal investigator, U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464498
- Sponsor's protocol ID
- MDG20180000
- Acronym
- AKITENMED
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.
- ClinicalTrials.gov ID
- NCT05464498
- Acronym / sponsor ID
- AKITENMED / MDG20180000
- Keywords
- Eccentric strengthening, Collagene Medical Device, Physiotherapy, Peritendinous area, Infiltration, Type I collagen, Eccentric strengthening protocol, Pain Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Guna S.p.aIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In view of the morpho-structural changes that characterize Achilles tendinopathy, the use of injectable medical devices such as Collagen Medical Devices might find therapeutic indication. For some years now, in fact, the use of injectable medical devices based on porcine collagen and ancillary substances of natural origin (Collagen Medical Devices GUNA) has been introduced in the treatment of painful and degenerative pathologies of the locomotor system, which allow a more effective and specific placement of collagen in situ with the function of vehiculation and stabilization.
The purpose of this research project is to understand through a multicenter, randomized clinical study investigation the impact of treatment with a porcine Collagen-based Medical Device called MD-Tissue, administered in the peri-tendon area, in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.
The multicenter, randomized clinical investigation is prospective, and will have a total duration of 8 weeks.
After enrollment, subjects will be randomized and assigned to two experimental groups:
- Group A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device.
- Group B which, will implement only physiotherapy (eccentric strengthening protocol).
Variables will be assessed at baseline (T0 time), after 1 week (T1), after 2 weeks (T2), after 3 weeks (T3), at the end of the injection treatment, and 6 weeks after enrollment (T6/FU). A further evaluation will be carried out after 2 weeks and after 8 weeks T8/FU from the start of the investigation study.
After enrollment, subjects in both groups will begin a physiotherapy course (eccentric strengthening protocol), lasting 6 weeks. Each session will consist of stretching exercises of the Achilles tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD-Tissue Medical Device | Experimental | Device: MD-Tissue Collagen Medical Device, Other: eccentric strengthening protocolGroup A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device. |
| Eccentric strengthening protocol | Other | Other: eccentric strengthening protocolGroup B who will only perform physiotherapy (eccentric strengthening protocol). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects aged 18 to 70 years;
- Subjects with tendon pain for not more than 24 weeks;
- Subjects with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy;
- Subjects with a VISA A score between 50 and 75;
- VAS ≥ 5;
Key exclusion criteria (15 listed)
- subjects who have had surgery in the investigated area or lower extremity;
- subjects who have previously undergone physiotherapy.
- subjects with autoimmune diseases;
- subjects with peripheral neuropathy;
- subjects with calcific tendinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD-Tissue Collagen Medical DeviceMD-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). | Device | MD-Tissue Medical Device |
| eccentric strengthening protocolGroup B which, will implement only physiotherapy (eccentric strengthening protocol) | Other | Eccentric strengthening protocol, MD-Tissue Medical Device |
Primary outcome
Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon.
Time frame: Weeks 8
The primary end point will be assessed at week 8 and will involve: Assessment of the VISA-A questionnaire score at time weeks 8 compared to day 0. A difference between the two groups of 12 out of 100 points on the questionnaire can be considered clinically significant. We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon.
6 secondary outcomes
Assessment of the VISA-A (Victorian Institute of Sport Assessment- Achilles) questionnaire score at T3 and T6 weeks, ranging from 0 to 100 points, where 100 points represents a healthy tendon.
Time frame: Weeks 3, weeks 6.
Assessment of the VAS (Visual Analogue Scale) at time weeks 3, weeks 6 and weeks 8, allows the patient to define pain intensity along a line from 0 to 10 cm (100 mm).
Time frame: Weeks 3, weeks 6, weeks 8
Evaluation of the SF12 (Item Short Form Survey) questionnaire at times weeks 3, weeks 6 and weeks 8 determinated the phisical condition and mental healthy functioning.
Time frame: Weeks 3, weeks 6 and weeks 8.
Evaluation of the fraction of subjects in each group achieving Minimal Clinical Disease (MCD) considering that the MCD of the VISA-A questionnaire is 18.5 (90% MCD).
Time frame: Day 0, week 1, weeks 2,weeks 3, weeks 6 and weeks 8.
Assessment of analgesic drug unit consumption based on clinical diary
Time frame: Weeks 3,weeks 6 and weeks 8.
Evaluation of the fraction of subjects in each group who drop out early in relation to Adverse Events (AE/SAE/SUSAR)
Time frame: Day 0, week 1,weeks 2,weeks 3,weeks 6 and weeks 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paoloni PM Marco, Prof principal investigator
U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-Tissue Collagen Medical Device and eccentric strengthening protocol in people with Tendinopathy and Insertional Achilles Tendinopathy, run by Guna S.p.a at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda MV Vincenzo, Dr (3351311917 ext. +39, v.miranda@guna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon. (time frame: Weeks 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.