Achilles Tendon TearPhase 2/3NCT00731068
Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears
A Phase 2/3 study testing PRGF in people with Achilles Tendon Tear, run by Meir Medical Center.
Trial summary
To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Achilles Tendon Tear
- What is being tested?
- PRGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A complete tear of Achilles tendon
- Age 18-50 years old
Who cannot join
- under 18 year of age
- pregnancy
- physical or mental disabilities
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Tendon Tear
- Being tested
- PRGF, placebo
- Keywords
- Achilles tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGFBiological
Also called platelet-derived preparation rich in growth factors
injection of 6cc into injured area of tendon
placeboBiological
Also called saline 0.9% nacl
injection of 6 cc of saline into injured area
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PRGF Receives: Biological: PRGF |
| 2 | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of symptoms / disease progress
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Mei Dan, Dr, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731068
- Sponsor's protocol ID
- 2000
- Other IDs
- MeirMc07om0090CTIL
- Status last verified
- Oct 2013
- First submitted
- 5 Aug 2008
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail
- ClinicalTrials.gov ID
- NCT00731068
- Acronym / sponsor ID
- 2000
- Conditions
- Achilles Tendon Tear
- Keywords
- Achilles tendon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: PRGFPRGF |
| 2 | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A complete tear of Achilles tendon
- Age 18-50 years old
Key exclusion criteria (3 listed)
- under 18 year of age
- pregnancy
- physical or mental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRGFAlso: platelet-derived preparation rich in growth factorsinjection of 6cc into injured area of tendon | Biological | 1 |
| placeboAlso: saline 0.9% naclinjection of 6 cc of saline into injured area | Biological | 2 |
Primary outcome
improvement of symptoms / disease progress
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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Achilles Tendon Rupture Patient Outcomes at 12 Months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Mei Dan, Dr principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRGF in people with Achilles Tendon Tear, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of symptoms / disease progress (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.