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

Study acronym: AKITENMED
StatusRecruiting
PhaseNot applicable
SponsorGuna S.p.a
Started
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Record History

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  1. Study completion pushed from Jan 13, 2026 to Nov 1, 2026v11
  2. Study completion date: Jul 13, 2025 to Jan 13, 2026v10
  3. Primary completion date: Feb 13, 2023 to Feb 13, 2024v9
  4. Study completion date: Jul 13, 2024 to Jul 13, 2025v8
  5. Re-verified, no change to tracked fieldsv7
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  1. Eligibility criteria revisedv6
  2. Study completion date: Jun 13, 2023 to Jul 13, 2024v5
  3. Primary completion date changed from estimate of Apr 13, 2023 to Feb 13, 2023v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05464498
Lead Sponsor Guna S.p.a
Conditions
(from sponsor)		 Tendinopathy, Insertional Achilles Tendinopathy, Achilles Tendinopathy, Peritendinitis
Related terms Osteogenesis Imperfecta, Type IV, Tendinopathy, Tenosynovitis
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov