NCT00725907

Brief Summary

PRP will enhance ATFL tears healing by time and quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

July 29, 2008

Last Update Submit

July 10, 2011

Conditions

Soft Tissue Healing

Keywords

PRPATFL

Outcome Measures

Primary Outcomes (1)

  • time to return to active sport

    2

Study Arms (2)

1

EXPERIMENTAL

PGRF

Biological: PGRF

2

PLACEBO COMPARATOR

saline

Biological: placebo saline

Interventions

PGRFBIOLOGICAL

injection of 6cc into injured area

1
placebo salineBIOLOGICAL

injection of 6cc into injured area

2

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • athletes 18-30 years old 1st sprain within 3 days from injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Study Officials

  • omer mei-dan, MD

    Meir Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

July 12, 2011

Record last verified: 2011-07

Locations

IL(1)