Soft Tissue HealingNCT00725907
Treatment of ATFL Tears With PRP
A study testing PGRF in people with Soft Tissue Healing, run by Meir Medical Center at 1 site in Israel.
Trial summary
PRP will enhance ATFL tears healing by time and quality. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Healing
- What is being tested?
- PGRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jan 2009
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- athletes 18-30 years old 1st sprain within 3 days from injury
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of ATFL Tears After Ankle Sprains With PRP
PRP will enhance ATFL tears healing by time and quality.
- Conditions
- Soft Tissue Healing
- Being tested
- PGRF, placebo saline
- Keywords
- PRP, ATFL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGRFBiological
injection of 6cc into injured area
placebo salineBiological
injection of 6cc into injured area
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PGRF Receives: Biological: PGRF |
| 2 | Placebo comparator | saline Receives: Biological: placebo saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to return to active sport
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue HealingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- omer mei-dan, MD, Study director, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725907
- Sponsor's protocol ID
- 6000
- Other IDs
- MeirMc07om0091CTIL
- Status last verified
- Jul 2011
- First submitted
- 29 Jul 2008
- Last updated
- 12 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of ATFL Tears After Ankle Sprains With PRP
- ClinicalTrials.gov ID
- NCT00725907
- Acronym / sponsor ID
- 6000
- Conditions
- Soft Tissue Healing
- Keywords
- PRP, ATFL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Jul 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.
PRP will enhance ATFL tears healing by time and quality.
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: PGRFPGRF |
| 2 | Placebo comparator | Biological: placebo salinesaline |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- athletes 18-30 years old 1st sprain within 3 days from injury
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PGRFinjection of 6cc into injured area | Biological | 1 |
| placebo salineinjection of 6cc into injured area | Biological | 2 |
Primary outcome
time to return to active sport
Time frame: 2
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 12 Jul 2011.
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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, MD study director
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGRF in people with Soft Tissue Healing, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 0 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
time to return to active sport (time frame: 2). 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 12 Jul 2011.