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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00731068
First received: August 5, 2008
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Achilles Tendon Tear
Biological: PRGF
Biological: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • improvement of symptoms / disease progress [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731068

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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00731068     History of Changes
Other Study ID Numbers: 2000, MeirMc07om0090CTIL
Study First Received: August 5, 2008
Last Updated: October 23, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:
Achilles tendon

ClinicalTrials.gov processed this record on November 24, 2014