WoundsEarly Phase 1AmnionNCT00592189
Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients
A Early Phase 1 study testing blood draw in people with Wounds, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious. Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair. Read more about this study
- Who is it for?
- Ages 16 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jun 2014
- Phase
- Early Phase 1
- 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 16 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women
- Pregnant, delivery expected within the month
Who cannot join
- Known history of hepatitis, HIV, or active transmissable diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Fetal Membrane as a New Coverage Material
Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious.
Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.
- Conditions
- Wounds
- Being tested
- blood draw
- Keywords
- Burns, Wound healing, Amnion
- Medical subject headings
- Wounds and Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
blood collection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amnion tissue and blood collection Receives: Procedure: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe method of obtaining and processing amnion
Measured: 0-21 days post harvest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 1999
- Primary completionJun 2014
- Study completionJun 2014
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 The University of Texas Medical Branch, GalvestonThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592189
- Sponsor's protocol ID
- 1999-209
- Other IDs
- Clayton
- Acronym
- Amnion
- Status last verified
- Jun 2014
- First submitted
- 26 Dec 2007
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Membrane as a New Coverage Material
- ClinicalTrials.gov ID
- NCT00592189
- Acronym / sponsor ID
- Amnion / 1999-209
- Conditions
- Wounds
- Keywords
- Burns, Wound healing, Amnion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jan 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.
Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious.
Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: blood drawAmnion tissue and blood collection |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women
- Pregnant, delivery expected within the month
Key exclusion criteria (1 listed)
- Known history of hepatitis, HIV, or active transmissable diseases
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 |
|---|---|---|
| blood drawblood collection | Procedure or surgery | 1 |
Primary outcome
Safe method of obtaining and processing amnion
Time frame: 0-21 days post harvest
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 Jun 2014.
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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 N Herndon, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing blood draw in people with Wounds, run by The University of Texas Medical Branch, Galveston 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 1 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 Jun 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Safe method of obtaining and processing amnion (time frame: 0-21 days post harvest). 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 Jun 2014.