Difficult to Heal WoundsPhase 1MSCsNCT02668042
The Activity of Tissue Engineering Skin Substitutes
A Phase 1 study testing liveness tissue skin in people with Difficult to Heal Wounds, run by Chinese PLA General Hospital.
Trial summary
The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult to Heal Wounds
- What is being tested?
- liveness tissue skin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- 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 70 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
- 3 months participated in other similar experiment
- Serious infectious disease not controller
- With surgery, such as severe trauma stress situation
- Can not meet the requirement of the long-term follow-up of patients
About this study
Official title: Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds
The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds
Read the detailed description
This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.
- Conditions
- Difficult to Heal Wounds
- Being tested
- liveness tissue skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liveness tissue skinBiological
liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds
| Study group | Role | What they receive |
|---|---|---|
| liveness tissue skin | Experimental | Not described Receives: Biological: liveness tissue skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Frequency and severity of Adverse Events
Measured: 6 months
Secondary outcomes (1)
Relative Wound Area Regression of 40% or More at 6 Week
Measured: 6 week
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 Difficult to Heal 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, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668042
- Sponsor's protocol ID
- CHIH-PLAGH-ST-006
- Acronym
- MSCs
- Status last verified
- Jan 2016
- First submitted
- 21 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
- Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds
- ClinicalTrials.gov ID
- NCT02668042
- Acronym / sponsor ID
- MSCs / CHIH-PLAGH-ST-006
- Conditions
- Difficult to Heal Wounds
- 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.
The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds
Detailed description
This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liveness tissue skin | Experimental | Biological: liveness tissue skin |
Who may qualify
- Ages
- 17 to 70 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 (8 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
- 3 months participated in other similar experiment
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 |
|---|---|---|
| liveness tissue skinliveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds | Biological | liveness tissue skin |
Primary outcome
Frequency of Adverse Events
Time frame: 6 months
Frequency and severity of Adverse Events
1 secondary outcome
Relative Wound Area Regression of 40% or More at 6 Week
Time frame: 6 week
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.
Related trials for Difficult to Heal Wounds
Recruiting
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
Wounds and Injuries / Mortality
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
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liveness tissue skin in people with Difficult to Heal Wounds, run by Chinese PLA General Hospital.
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 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.