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

NCT05464498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-08-03

No results posted yet for this study

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

Interventions

DEVICE

MD-Tissue Collagen Medical 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).

OTHER

eccentric strengthening protocol

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

Sponsors & Collaborators

  • Guna S.p.a

    lead INDUSTRY

Principal Investigators

  • Paoloni PM Marco, Prof · U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" Piazzale Aldo Moro, 5 00185 Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2024-02-13
Completion
2026-01-13

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464498 on ClinicalTrials.gov