Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department

A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01518335

Acronym

PRP

Enrollment

Registered

2012-01-26

Start date

2009-06-30

Completion date

2012-02-29

Last updated

2017-05-10

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

Conditions

Sprain of Ankle

Keywords

platelet rich plasma, ankle, sprain, injection, Platelet Rich Plasma therapy, focal, invasive therapy for sprains

Brief summary

This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.

Detailed description

The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.

Interventions

PROCEDUREPlatelet rich plasma injection

50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.

PROCEDUREPlacebo Comparator: Placebo/Standard of Care

50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* severe ankle sprain * X-ray completed

Exclusion criteria

* Pregnancy/breastfeeding * Police custody * active infection * metastatic disease/tumors * History of thrombocytopenia * Allergy to ester or amine anesthetics * On anticoagulant medication * Peripheral vascular disease * Known coagulopathy

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.	Day 0; Day2-3; Day 8-10; Day30	The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.

Secondary

Measure	Time frame	Description
Change in pain from baseline	Day 0; Day 2-3, Day 8-10, Day 30	Changes in level of pain from baseline was measured using VAS scale as well as comparing need for narcotics use at each follow up time point.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026