NCT00731068

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

August 5, 2008

Last Update Submit

October 23, 2013

Conditions

Achilles Tendon Tear

Keywords

Achilles tendon

Outcome Measures

Primary Outcomes (1)

  • improvement of symptoms / disease progress

    1 year

Study Arms (2)

1

EXPERIMENTAL

PRGF

Biological: PRGF

2

PLACEBO COMPARATOR
Biological: placebo

Interventions

PRGFBIOLOGICAL

injection of 6cc into injured area of tendon

Also known as: platelet-derived preparation rich in growth factors
1
placeboBIOLOGICAL

injection of 6 cc of saline into injured area

Also known as: saline 0.9% nacl
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Intercellular Signaling Peptides and ProteinsSodium Chloride

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Omer Mei Dan, Dr

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

February 1, 2007

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

October 24, 2013

Record last verified: 2013-10