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Recruiting NCT07558564

Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

Observational Patellar Tendinopathy Achilles Tendinopathy (AT) Epicondylitis, Lateral Plantar Fasciitis, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet rich plasma (PRP).
Who it may be relevant to
Registry conditions: Patellar Tendinopathy, Achilles Tendinopathy (AT), Epicondylitis, Lateral, Plantar Fasciitis, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multicenter Real-World Evidence (RWE) Study: Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

Overview

This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterization, clinical variables, treatment protocols, and longitudinal assessment of therapeutic response.

Interventions

  • Biological Platelet rich plasma (PRP)
    A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (u

Primary outcome measures

  • Visual Analog Scale [Time frame: From baseline up to 12 months post-treatment]
  • VISA-P [Time frame: baseline, 1 month, 3 months, 6 months and 12 months]
  • VISA-A [Time frame: baseline, 1 month, 3 months, 6 months and 12 months]
  • Patient Rated Tennis Elbow Evaluation Scale [Time frame: baseline, 1 month, 3 months, 6 months and 12 months]
  • Foot Function Index [Time frame: baseline, 1 month, 3 months, 6 months and 12 months]
Secondary outcome measures (2)
  • Predictive factors of response to PRP treatment [Time frame: baseline]
  • Adverse events [Time frame: 1 month, 3 months, 6 months, 12 months]

Eligibility criteria

Inclusion criteria

  • Clinical and/or ultrasound diagnosis of chronic tendinopathy (duration >6 weeks)
  • Age >18 years
  • Provision of written informed consent
  • Willingness and ability to complete follow-up assessments for 12 months

Exclusion criteria

  • Surgical treatment of the affected tendon within the previous 6 months
  • Corticosteroid injection within the last month
  • Systemic inflammatory disease (e.g., rheumatoid arthritis)
  • Coagulopathies or ongoing anticoagulant therapy
  • Complete blood count showing a platelet concentration <100 × 10⁹/L (to exclude patients with potential thrombocytopenia)
  • Pregnancy or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 5 centers
  • Instituto Médico Arriaza — A Coruña
  • Instituto Cugat — Barcelona
  • ReSport Clinic — Barcelona
  • Ripoll y dePrado Medical Group — Madrid
  • Hospital MIKS — Vitoria-Gasteiz

Identifiers

NCT: NCT07558564 · RWE-TDP-20251206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗