NCT01518335.
Trial name or title | A double blind, randomised, placebo controlled study evaluating the use of platelet rich plasma therapy for acute ankle sprains in the Emergency Department |
Methods | Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: double blind (subject, caregiver) |
Participants | Location: not reported Target sample size (N): 38 Inclusion criteria: severe ankle sprain, X‐ray completed Exclusion criteria: pregnancy/breastfeeding; police custody; active infection; metastatic disease/tumours; history of thrombocytopenia; allergy to ester or amine anaesthetics; taking anticoagulant medication; peripheral vascular disease; known coagulopathy |
Interventions |
PRP: platelet rich plasma injection (details not reported) Controls or placebo or no intervention (standard care): standard care |
Outcomes | Primary outcomes: LEFS Secondary outcomes: change in pain from baseline (details not reported) Timing of outcomes measurement: day 0; days 2‐3, days 8‐10, day 30 |
Starting date |
Main ID: NCT01518335
Date of registration: December 2011 Last refreshed on: February 2013 Date of first enrolment: June 2009 Status: completed |
Contact information | Name: Adam Rowden Address: not reported Telephone: not reported Email: not reported Affiliation: Einstein Healthcare Network |
Notes |