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

NCT ID: NCT00731068

Last Updated: 2013-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Achilles Tendon Tear

Keywords

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Achilles tendon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

PRGF

Group Type EXPERIMENTAL

PRGF

Intervention Type BIOLOGICAL

injection of 6cc into injured area of tendon

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

injection of 6 cc of saline into injured area

Interventions

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PRGF

injection of 6cc into injured area of tendon

Intervention Type BIOLOGICAL

placebo

injection of 6 cc of saline into injured area

Intervention Type BIOLOGICAL

Other Intervention Names

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platelet-derived preparation rich in growth factors saline 0.9% nacl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omer Mei Dan, Dr

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Other Identifiers

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MeirMc07om0090CTIL

Identifier Type: -

Identifier Source: secondary_id

2000

Identifier Type: -

Identifier Source: org_study_id