WoundsNCT00125086
Platelets for Acute Wound Healing
A study testing autologous platelet gel in people with Wounds, run by Medtronic at 1 site in United States.
Trial summary
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- autologous platelet gel
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal volunteers
- 18 years old or older
Who cannot join
- Pregnant or lactating
- Diabetic, keloid former, collagen vascular disease
- Smoker
- Body mass index >30kg/m2
- Known history of HIV/AIDS; Hepatitis A, B, or C
- Bleeding disorder
- Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
- Cancer, or treatment for cancer, in past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.
Read the detailed description
Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors.
According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury.
Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.
- Conditions
- Wounds
- Being tested
- autologous platelet gel
- Keywords
- wounds, healing, Acute wounds healing by secondary intention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet gelDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
Secondary outcomes (2)
Measurements of wound depth at each visit
Measurement of residual scarring at 6 months post wounding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startJul 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- 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
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Hom, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125086
- Sponsor's protocol ID
- APG-01-0605
- Other IDs
- APG-01-0605
- Status last verified
- Sep 2005
- First submitted
- 27 Jul 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
- ClinicalTrials.gov ID
- NCT00125086
- Acronym / sponsor ID
- APG-01-0605
- Conditions
- Wounds
- Keywords
- wounds, healing, Acute wounds healing by secondary intention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Feb 2006
- First posted
- 29 Jul 2005 (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.
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.
Detailed description
Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors.
According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury.
Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal volunteers
- 18 years old or older
Key exclusion criteria (8 listed)
- Pregnant or lactating
- Diabetic, keloid former, collagen vascular disease
- Smoker
- Body mass index >30kg/m2
- Known history of HIV/AIDS; Hepatitis A, B, or C
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 |
|---|---|---|
| autologous platelet gel | Device | – |
Primary outcome
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
2 secondary outcomes
Measurements of wound depth at each visit
Measurement of residual scarring at 6 months post wounding
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 14 Sep 2005.
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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.
David Hom, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous platelet gel in people with Wounds, run by Medtronic at 1 site in United States.
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 8 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 14 Sep 2005. 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 United States. 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. 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 100% wound closure, measured at Days 7, 14, 21, 28, 35. 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 14 Sep 2005.