Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

NCT05464498 | Recruiting

• 1 other identifier: MDG20180000
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Tendinopathy; Insertional Achilles Tendinopathy; Achilles Tendinopathy; Peritendinitis

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

Outcome Measures

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.

  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.

  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).

  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.

  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).

  Day 0, week 1, weeks 2,weeks 3, weeks 6 and weeks 8.

• Assessment of analgesic drug unit consumption based on clinical diary

  Weeks 3,weeks 6 and weeks 8.

Study Arms (2)

MD-Tissue Medical Device

EXPERIMENTAL

Group A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device.

Device: MD-Tissue Collagen Medical Device; Other: eccentric strengthening protocol

Eccentric strengthening protocol

OTHER

Group B who will only perform physiotherapy (eccentric strengthening protocol).

Other: eccentric strengthening protocol

Interventions

MD-Tissue Collagen Medical Device DEVICE

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).

MD-Tissue Medical Device

eccentric strengthening protocol OTHER

Group B which, will implement only physiotherapy (eccentric strengthening protocol)

Eccentric strengthening protocol; MD-Tissue Medical Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Guna S.p.a: lead

Study Sites (1)

U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°"

Roma, RO, 00185, Italy

RECRUITING

MeSH Terms

Conditions

Tendinopathy; Tenosynovitis; Osteogenesis Imperfecta, Type IV

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Paoloni PM Marco, Prof

  U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda MV Vincenzo, Dr

CONTACT

3351311917; v.miranda@guna.it

Laarej Kamilia, Dr

CONTACT

0228018359; k.laarej@guna.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: June 13, 2022
• Primary Completion: February 13, 2024
• Study Completion: January 13, 2026
• Last Updated: August 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)