WoundsPhase 1MA/GHNCT01824381
Use of the Amniotic Membrane in Large Wound Epithelialization
A Phase 1 study testing Place amniotic membrane in large wounds, Obtaining and Cryopreservation of amniotic membrane and amniotic membrane in people with Wounds, run by Red de Terapia Celular at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- Place amniotic membrane in large wounds, Obtaining and Cryopreservation of amniotic membrane and amniotic membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Mar 2017
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute wounds in granulation phase with a minimum area of 100 cm2.
- Patients 18 or more years.
- Patients offering sufficient guarantees of adherence to protocol.
- Sign the written informed consent.
- Meet all inclusion criteria.
Who cannot join
- Patients with symptomatic chronic arterial insufficiency.
- Patients who are pregnant
- Patients in active lactation
- Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
- Complete abstinence from sexual intercourse
- Surgical sterilization (tubal ligation)
Show all 13Show fewer
- Surgical sterilization of the partner (vasectomy)
- Implanted or injectable hormonal contraceptives, oral *
- Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control.
- These reliable contraception must be maintained during their participation in the study.
- Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test.
- Participation in other clinical trials.
- Inability to understand informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
About this study
Official title: Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
- Conditions
- Wounds
- Being tested
- Place amniotic membrane in large wounds, Obtaining and Cryopreservation of amniotic membrane, amniotic membrane
- Keywords
- extensive wounds, amniotic membrane, healing, patients, phase granulation
- 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.
Place amniotic membrane in large woundsProcedure or surgery
After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed.
The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue.
We will place a new membrane weekly to a maximum of 6 times.
Obtaining and Cryopreservation of amniotic membraneProcedure or surgery
amniotic membraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane in large wounds | Experimental | Not described Receives: Procedure: Place amniotic membrane in large wounds; Procedure: Obtaining and Cryopreservation of amniotic membrane; Drug: amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
No serious adverse events possibly, probably or definitely related with the procedure.
No appearance of clinical inflammatory changes.
Measured: Last revision at 3 years after surgery.
Secondary outcomes (3)
Measurement of the wound area
To assess the effects of the application of the amniotic membrane on reepithelialization of wounds by measuring the wound area.
Measured: 3 years
Evolution of local pain measured with a visual analog scale
To assess the effects of the application of amniotic membrane in the symptomatology of patients through the development of local pain measured with a visual analog scale.
Measured: 1 year
Changes in the signaling pathways of TGFb.
To study the changes in the signaling pathways of TGFb in patients epithelium induced amniotic membrane.
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 posted4 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2017
- Study completionMar 2017
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Public Health Service, Murcia, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, MurciaSalud
- Responsible party
- Sponsor
- Investigators
- Gregorio Castellanos-Escrig, MD, Principal investigator, Clinical Universitary Hospital Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824381
- Sponsor's protocol ID
- MA/GH
- Other IDs
- 2011-004395-11
- Acronym
- MA/GH
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
- ClinicalTrials.gov ID
- NCT01824381
- Acronym / sponsor ID
- MA/GH / MA/GH
- Conditions
- Wounds
- Keywords
- extensive wounds, amniotic membrane, healing, patients, phase granulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Public Health Service, Murcia, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, MurciaSalud
- Study start
- Jul 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Apr 2013 (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.
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane in large wounds | Experimental | Procedure: Place amniotic membrane in large wounds, Procedure: Obtaining and Cryopreservation of amniotic membrane, Drug: amniotic membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute wounds in granulation phase with a minimum area of 100 cm2.
- Patients 18 or more years.
- Patients offering sufficient guarantees of adherence to protocol.
- Sign the written informed consent.
- Meet all inclusion criteria.
Key exclusion criteria (13 listed)
- Patients with symptomatic chronic arterial insufficiency.
- Patients who are pregnant
- Patients in active lactation
- Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
- These reliable contraception must be maintained during their participation in the study.
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 |
|---|---|---|
| Place amniotic membrane in large woundsAfter the process of obtaining the amniotic membrane, it must be processed, frozen and thawed. The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue. We will place a new membrane weekly to a maximum of 6 times. | Procedure or surgery | Amniotic membrane in large wounds |
| Obtaining and Cryopreservation of amniotic membrane | Procedure or surgery | Amniotic membrane in large wounds |
| amniotic membrane | Drug | Amniotic membrane in large wounds |
Primary outcome
Safety
Time frame: Last revision at 3 years after surgery.
No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes.
3 secondary outcomes
Measurement of the wound area
Time frame: 3 years
Evolution of local pain measured with a visual analog scale
Time frame: 1 year
Changes in the signaling pathways of TGFb.
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 30 Mar 2017.
- Fundación para la Formación e Investigación Sanitarias Región de MurciaLink provided by the sponsor.
- Official web of Health Service of Murcia Region.Link provided by the sponsor.
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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.
Gregorio Castellanos-Escrig, MD principal investigator
Clinical Universitary Hospital Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Place amniotic membrane in large wounds, Obtaining and Cryopreservation of amniotic membrane and amniotic membrane in people with Wounds, run by Red de Terapia Celular at 1 site in Spain.
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 5 inclusion and 13 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 30 Mar 2017. 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 Spain. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety (time frame: Last revision at 3 years after surgery.). 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 30 Mar 2017.