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

NCT07558564 | Recruiting

• 1 other identifier: RWE-TDP-20251206
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

tendinopathy, Real World Evidence (RWE), platelet-rich plasma, plantar fasciosis, epicondylitis, patellar tendon, Achilles tendon

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale

  From baseline up to 12 months post-treatment

• VISA-P

  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.

  baseline, 1 month, 3 months, 6 months and 12 months

• VISA-A

  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).

  baseline, 1 month, 3 months, 6 months and 12 months

• Patient Rated Tennis Elbow Evaluation Scale

  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.

  baseline, 1 month, 3 months, 6 months and 12 months

• Foot Function Index

  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.

  baseline, 1 month, 3 months, 6 months and 12 months

Secondary Outcomes (2)

• Predictive factors of response to PRP treatment

  baseline

• Adverse events

  1 month, 3 months, 6 months, 12 months

Study Arms (4)

Patellar tendinopathy

Patellar tendinopathy treated with PRP

Biological: Platelet rich plasma (PRP)

Achilles tendinopathy

Achilles tendinopathy treated with PRP

Biological: Platelet rich plasma (PRP)

Plantar fasciosis

Plantar fasciosis treated with PRP

Biological: Platelet rich plasma (PRP)

Chronic epycondylitis

Chronic epycondylitis treated with PRP

Biological: Platelet rich plasma (PRP)

Interventions

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

Achilles tendinopathy; Chronic epycondylitis; Patellar tendinopathy; Plantar fasciosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>18 years), of both sexes, diagnosed with patellar, Achilles, epicondylar tendinopathy or plantar fasciosis, who have received PRP treatment according to physician discretion.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReSport Clinic: lead
• BioSmartData: collaborator

Study Sites (5)

Instituto Médico Arriaza

A Coruña, 15009, Spain

RECRUITING

Instituto Cugat

Barcelona, 08023, Spain

RECRUITING

ReSport Clinic

Barcelona, 08029, Spain

RECRUITING

Ripoll y dePrado Medical Group

Madrid, 28010, Spain

RECRUITING

Hospital MIKS

Vitoria-Gasteiz, 01010, Spain

RECRUITING

MeSH Terms

Conditions

Tennis Elbow; Fasciitis, Plantar; Tendinopathy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Fasciitis; Foot Diseases

Study Officials

• Ferran Abat Gonzalez, MD PhD

  ReSport Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Resport Clinic, MD PhD

CONTACT

+34 93 2778709; abat@resportclinic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)