Completed

Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability

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What is being tested

Platelet-rich plasma

+ Control

Other
Who is being recruted

Leg Injuries

+ Wounds and Injuries

+ Ankle Injuries

From 20 to 60 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2016
See protocol details

Summary

Principal SponsorPei-Yuan Lee, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 5, 2016

Actual date on which the first participant was enrolled.

Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been linked to recurrent ankle pain, swelling, and even early degenerative change if not properly treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the mainstream in treatment of CAI. Early mobilization is related to better functional outcome, and rapid healing of the repair is the key point to shorten the immobilization time. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The postoperative imaging and clinical outcomes will be compared and analyzed.

Official TitleEfficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
NCT03197428
Principal SponsorPei-Yuan Lee, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Leg InjuriesWounds and InjuriesAnkle Injuries

Criteria

2 inclusion criteria required to participate
Age between 20 and 60 years
With diagnosis of chronic lateral ankle instability
8 exclusion criteria prevent from participating
Poor controlled diabetes
Peripheral artery obstructive disease
Skin or soft tissue infection at ankle
With current or prior history of ankle disease, including degeneration arthritis, fracture, deformity, and cartilage disease.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Group II

Placebo
15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Show Chwan Memorial Hospital

Changhua, TaiwanOpen Show Chwan Memorial Hospital in Google Maps
CompletedOne Study Center