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

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ClinicalTrials.gov Identifier: NCT00731068
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : October 24, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Achilles Tendon Tear Biological: PRGF Biological: placebo Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail
Study Start Date : February 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
PRGF
Biological: PRGF
injection of 6cc into injured area of tendon
Other Name: platelet-derived preparation rich in growth factors
Placebo Comparator: 2 Biological: placebo
injection of 6 cc of saline into injured area
Other Name: saline 0.9% nacl



Primary Outcome Measures :
  1. improvement of symptoms / disease progress [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731068


Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Omer Mei Dan, Dr Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00731068     History of Changes
Other Study ID Numbers: 2000
MeirMc07om0090CTIL
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Meir Medical Center:
Achilles tendon