Non-pressure Chronic Ulcer of Skin, Not Elsewhere ClassifiedNCT01724710
To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast
An observational study of Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Aug 2013
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. The process of collecting chronic ulcer skin: When the patient accept wound debridement surgery, visiting staff will take 1x1cm2 skin of chronic ulcer. 2. The process of collecting normal skin: When the patient accept skin-grafting surgery, visiting staff will take 1x1x0.1cm3 skin.
Who may be able to join
- chronic ulcer
- normal skin
- age 50~80 years,
- chronic skin ulcer patient
- skin-grafting patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Kean Eng Yeong, college, 886-2-23123456 ext. 65648, smartpace88@hotmail.com
About this study
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.
The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.
In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.
Expect clinical application of light therapy in the future is more accurate and effective.
Read the detailed description
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.
Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted therapy and photostimulation.
Although there are many treatments but no one has been widely accepted. The clinical effects of uncertainty, high cost and inconvenience of use is the main reason.
Each year amputation of the population due to chronic ulcers has not decreased. In order to break the current medical difficulties, We refer to the new light therapy technology.
Look forward to shorten the healing time and reduce medicine costs. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.
In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.
Expect clinical application of light therapy in the future is more accurate and effective irradiative time points and dosage.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic ulcer | 1x1cm2 tissue from chronic ulcer wound | |
| normal skin | 1x1x0.1 cm3 normal skin from graft |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-pressure Chronic Ulcer of Skin, Not Elsewhere ClassifiedStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kean Eng Yeong, college, Study chair, NTUH Burn lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724710
- Sponsor's protocol ID
- 201206038RIC
- Status last verified
- Nov 2012
- First submitted
- 28 Aug 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast
- ClinicalTrials.gov ID
- NCT01724710
- Acronym / sponsor ID
- 201206038RIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 12 Nov 2012 (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.
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.
The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.
In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.
Expect clinical application of light therapy in the future is more accurate and effective.
Detailed description
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.
Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted therapy and photostimulation.
Although there are many treatments but no one has been widely accepted. The clinical effects of uncertainty, high cost and inconvenience of use is the main reason.
Each year amputation of the population due to chronic ulcers has not decreased. In order to break the current medical difficulties, We refer to the new light therapy technology.
Look forward to shorten the healing time and reduce medicine costs. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.
In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.
Expect clinical application of light therapy in the future is more accurate and effective irradiative time points and dosage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic ulcer | – | –1x1cm2 tissue from chronic ulcer wound |
| normal skin | – | –1x1x0.1 cm3 normal skin from graft |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The process of collecting chronic ulcer skin: When the patient accept wound debridement surgery, visiting staff will take 1x1cm2 skin of chronic ulcer. 2. The process of collecting normal skin: When the patient accept skin-grafting surgery, visiting staff will take 1x1x0.1cm3 skin.
Key inclusion criteria (5 listed)
- chronic ulcer
- normal skin
- age 50~80 years,
- chronic skin ulcer patient
- skin-grafting patient
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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.
Kean Eng Yeong, college study chair
NTUH Burn lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 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: status not confirmed, as of the sponsor's last update on 12 Nov 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kean Eng Yeong, college (886-2-23123456 ext. 65648, smartpace88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Nov 2012.