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NCT Number: NCT07558564

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

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.

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Key information

Conditions

Patellar Tendinopathy Achilles Tendinopathy (AT) Arm Injuries Elbow Injuries Elbow Tendinopathy Epicondylitis, Lateral Fasciitis Fasciitis, Plantar Foot Diseases Muscular Diseases Musculoskeletal Diseases Plantar Fasciitis, Chronic Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Médico Arriaza, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma (PRP)

Biological

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 (ultrasound-guided whenever feasible)

Number of treatment sessions and interval between sessions

Primary outcomes

  1. Visual Analog Scale

    Time frame: From baseline up to 12 months post-treatment

  2. VISA-P

    Time frame: baseline, 1 month, 3 months, 6 months and 12 months

    Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.

  3. VISA-A

    Time frame: baseline, 1 month, 3 months, 6 months and 12 months

    The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).

  4. Patient Rated Tennis Elbow Evaluation Scale

    Time frame: baseline, 1 month, 3 months, 6 months and 12 months

    The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item self-report questionnaire designed to measure pain and functional disability in patients with lateral epicondylitis (tennis elbow). It includes a 5-item pain subscale and a 10-item function subscale, providing a total score out of 100 to assess, evaluate, and monitor recovery.

  5. Foot Function Index

    Time frame: baseline, 1 month, 3 months, 6 months and 12 months

    The Foot Function Index (FFI) is a 23-item, self-administered questionnaire designed to measure the impact of foot pathology on function, assessing pain, disability, and activity limitation. It uses a 0-10 Likert scale for items within three subscales, with higher total percentages (0-100%) indicating greater, more severe pain and dysfunction.

Secondary outcomes

  1. Predictive factors of response to PRP treatment

    Time frame: baseline

    Identify clinical patterns predictive of better PRP treatment response using multivariate analysis and artificial intelligence

  2. Adverse events

    Time frame: 1 month, 3 months, 6 months, 12 months

    Assess the incidence of local or systemic adverse events following PRP administration

Study contacts

Contact information is provided by the study sponsor or research team.

Resport Clinic, MD PhD

CONTACT

[email protected]

+34 93 2778709

Sponsors and collaborators

Lead sponsor

ReSport Clinic

Other

Collaborators

  • BioSmartData

Registry information

Official study title

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

Acronym: RWE-TDP-PRP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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