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Platelet rich plasma in Accelerated Tendo-achilles Healing

PATH: a prospective, randomised, controlled trial to investigate the clinical efficacy of platelet rich plasma in accelerating acute achilles tendon rupture healing and comparing it to traditional cast immobilisation treatment or operative treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93608625
Enrollment
360
Registered
2010-01-18
Start date
2009-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute achilles tendon rupture Injury, Occupational Diseases, Poisoning Injury of muscle and tendon at lower leg level

Interventions

Patients will follow a conservative or operative pathway according to the established protocol, which is determined depending on the tendo-achilles (TA) rupture gap size measured by ultrasound scan (U

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 - 55 years 3. Diagnosed with acute achilles tendon rupture 4. Presenting within 72 hours post-injury, due to sport activity or low energy hyper-dorsal flexion of the foot 5. Able (in the Investigators opinion) and willing to comply with all study requirements 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion criteria

Exclusion criteria: 1. Previous tendon injury 2. History of diabetes mellitus (DM) 3. Platelet abnormality or platelets count less than 100 x 10^9 /l 4. Haematological disorder 5. Serum haemoglobin less than 11 g/dl 6. Use of systemic cortisone 7. Use of any anticoagulant 8. Evidence of gangrene/ulcers or peripheral vascular disease 9. History of hepatic or renal impairment or dialysis 10. Patient is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements 11. History of alcohol or drug abuse 12. Patient has a religious or cultural conflict with the use of platelet gel treatment or blood products 13. Patient has inadequate venous access for blood draw 14. Patient is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study 15. Patient has evidence of Charcot foot/ankle joint 16. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 17. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Design outcomes

Primary

MeasureTime frame
Achilles tendon Total Rupture Score (ATRS), measured at 1, 3, 6, 8, 12 weeks

Secondary

MeasureTime frame
1. Functional ultrasound elastography scan, measured at 3 and 6 months 2. Foot and Ankle Outcome Score (FAOS), measured at 1, 3, 6, 8, 12 weeks 3. Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A), measured at 1, 3, 6, 8, 12 weeks 4. Range of movement, measured at 3 and 6 months 5. Maximum tip-toeing, measured at 3 and 6 months 6. 36-item short form health survey (SF-36), measured at 3 and 6 months 7. Re-rupture rate, measured at 3 and 6 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026