WoundsPhase 1TB4NCT02668055
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds
A Phase 1 study testing TB4 in people with Wounds, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security. Read more about this study
- Who is it for?
- Ages 17 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- TB4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2015
- 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 17 to 78 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meet difficult had 1 month or more to heal the wound patients
- Who signed the informed consent of men or women older than 17 (pregnancy)
- Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
- The process of mental stability, can finish the test
Who cannot join
- Known allergic to bovine collagen or gao min physique
- the wound is greater than the10cm×10cm
- People with mental illness, drug abusers and or other items
- Pregnant women,Prepare a pregnancy or breast feeding women 5.3 months participated in other similar experiment
- 6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.
- Conditions
- Wounds
- Being tested
- TB4
- Keywords
- TB4, Difficult to heal
- 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.
TB4Biological
Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface
| Study group | Role | What they receive |
|---|---|---|
| TB4 | Experimental | Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells in wound, stick with wound edge skin suture, with vaseline gauze bandaging, controlled side not adding slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes Receives: Biological: TB4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing
Measured: 6 months
Secondary outcomes (1)
Relative Wound Area Regression of 40% of More at 6 Week
Subsistence the wound tissue(4 mm ×4 mm) biopsy samples, to determine the wound repair
Measured: 6week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
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 Chinese PLA General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobing Fu, Chinese PLA General Hospital
- Investigators
- xiaobing Fu, Principal investigator, Chinee PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668055
- Sponsor's protocol ID
- CHIN-PLAGH-ST-005
- Acronym
- TB4
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies
- ClinicalTrials.gov ID
- NCT02668055
- Acronym / sponsor ID
- TB4 / CHIN-PLAGH-ST-005
- Conditions
- Wounds
- Keywords
- TB4, Difficult to heal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Jan 2016 (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.
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB4 | Experimental | Biological: TB4Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells in wound, stick with wound edge skin suture, with vaseline gauze bandaging, controlled side not adding slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes |
Who may qualify
- Ages
- 17 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meet difficult had 1 month or more to heal the wound patients
- Who signed the informed consent of men or women older than 17 (pregnancy)
- Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
- The process of mental stability, can finish the test
Key exclusion criteria (5 listed)
- Known allergic to bovine collagen or gao min physique
- the wound is greater than the10cm×10cm
- People with mental illness, drug abusers and or other items
- Pregnant women,Prepare a pregnancy or breast feeding women 5.3 months participated in other similar experiment
- 6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients
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 |
|---|---|---|
| TB4Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface | Biological | TB4 |
Primary outcome
Frequency of Adverse Events
Time frame: 6 months
Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing
1 secondary outcome
Relative Wound Area Regression of 40% of More at 6 Week
Time frame: 6week
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 29 Jan 2016.
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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.
xiaobing Fu principal investigator
Chinee PLA General Hospital
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 TB4 in people with Wounds, run by Chinese PLA General Hospital at 1 site in China.
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 4 inclusion and 5 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 29 Jan 2016. 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 China. 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?
Frequency of Adverse Events (time frame: 6 months). 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 29 Jan 2016.