Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuna S.p.a
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
MD-Tissue Collagen Medical Device
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).
eccentric strengthening protocol
Other interventionGroup B which, will implement only physiotherapy (eccentric strengthening protocol)
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: MD-Tissue Medical DeviceExperimental treatment 2 interventions
Group B: Eccentric strengthening protocolOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Weeks 8Secondary outcomes
1
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
Time frame
Weeks 3, weeks 6.2
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'.
Time frame
Weeks 3, weeks 6, weeks 83
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.
Time frame
Weeks 3, weeks 6 and weeks 8.4
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.
Time frame
Day 0, week 1, weeks 2,weeks 3, weeks 6 and weeks 8. Source ClinicalTrials.gov