clinical study on the efficacy of infiltrative echo-guided therapy with hyaluronic acid (500-730 KDa) (HYALGAN®) versus saline solution in the conservative treatment of Achilles tendinopathy. Subjects will be randomly assigned to one of these two groups of treatment. Both evaluator and patients are unaware of the treatment assigned. In the open label extension, patients with persistent pain can receive a second cycle of Hyalgan.

Phase 1

Conditions: Achilles tendinopathy
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-004117-40-IT

Lead Sponsor: Fidia Farmaceutici SpA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

-aged 18 to 70 included
-diagnosis of chronic (syntoms persisting for over 6 weeks) or subacute (syntoms persisting approximately 3-6 weeks) tendinitis of Achilles tendon, diagnosed clinically or/and by means of ultrasound.
-presence of at least one of the following parameters:
- thickening of tendon
- increased thermotouch,
- pain to palpation and pressure,
- VAS = 40 mm
- Limited range of motion;
-Total score VISA-A inclusion of less than 60;
-signing of informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

- Tendonitis in acute inflammatory phase (symptoms present for less than 3 weeks);
- Patients with lateral instability of the ankle;
- Obese patients with BMI> 35 kg/m2;
- History of diabetes mellitus or any other disease which, in the opinion of the investigator, would be able to influence the detection of experimental data;
- History of arthritic diseases and / or metabolic disorders;
- suspected (based on clinical judgment or tests) structural tendon lacerations (previous or current);
- serious previous trauma to the Achilles tendon;
- Patients with bilateral Achilles tendinopathy.
- Patient undergone previous surgery to the Achilles tendon under study or its ankle;
- Use of corticosteroids and fluoroquinolones for oral, parenteral or intra-articular in the three months prior to inclusion in the study;
- injection of hyaluronic acid in the Achilles tendon under evaluation in the three months prior to inclusion in the study;
- Patient pregnant;
- Participation in other clinical trials in the three months prior to inclusion in the study.