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To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast

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ClinicalTrials.gov Identifier: NCT01724710
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 12, 2012
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief 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.

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.


Condition or disease
Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified

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
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Groups and Cohorts
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Group/Cohort
chronic ulcer
1x1cm2 tissue from chronic ulcer wound
normal skin
1x1x0.1 cm3 normal skin from graft


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Fibroblasts of Chronic ulcer and normal skin will be cultured. Fibroblast culture will be analyzed with quantitative PCR.

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • chronic ulcer
  • normal skin
  • age 50~80 years,
  • chronic skin ulcer patient
  • skin-grafting patient

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724710


Contacts
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Contact: Kean Eng Yeong, college 886-2-23123456 ext 65648 smartpace88@hotmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Kean Eng Yeong, college    886-2-23123456 ext 65648    smartpace88@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Kean Eng Yeong, college NTUH Burn lab
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01724710    
Other Study ID Numbers: 201206038RIC
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012