Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears

October 23, 2013 updated by: Meir Medical Center

PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail

To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Autologous platelet-rich matrices may aid in post surgical patients by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A complete tear of Achilles tendon
  • Age 18-50 years old

Exclusion Criteria:

  • under 18 year of age
  • pregnancy
  • physical or mental disabilities

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Biological: placebo
injection of 6 cc of saline into injured area
Other Names:
  • saline 0.9% nacl
EXPERIMENTAL: 1
PRGF
Biological: PRGF
injection of 6cc into injured area of tendon
Other Names:
  • platelet-derived preparation rich in growth factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement of symptoms / disease progress
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000
  • MeirMc07om0090CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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