- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627702
Treatment of Bedsores With VIP Light
The Effect of VIP Light on Healing Bedsores Process
Difficulty healing wounds have a significant effect to the general fitness of the patient and his quality of life. On Account of the frequency of their appearing, constitute the serious health and social problem. In comprehensive dealing with such patients physiotherapy will matter greatly. The visible polychromatic polarized light is most often used physical factor assisting comprehensive treatment bedsores.
Purpose of the work: Analyze of using the visible polychromatic polarized light in the comprehensive process of healing bedsores at elderly people with the limited motor activity.
Material and methods: Participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. The study was conducted in people over 65 years old, with bedsores grade III and IV in Torrance scale. The therapy included radiation of bedsores with VIP light. Effectiveness of the method of treatment was examined using photographic images and to measure the extent of the wound.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- a high risk of bedsores development (Dutch Consensus Prevention of Bedsores CBO)
- having a bedsore(s)
- permanent stay in a nursing home
- recommended light therapy (VIP light)
Exclusion Criteria:
- ability to locomotion
- age under 65 years old
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Study group
All bedsores were irradiated with a Bioptron lamp.
Photo and measurement of bedsores size and Torrance score, were made: on the first, 9,18 and 36 day of therapy.
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20 irradiations were performed twice a day.
The exposure time was 10 minutes.
Exposure was made at a distance of 10 cm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
scale Dutch Consensus Prevention of Bedsores CBO
Time Frame: The first day of the therapy (one measure)
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Scale Dutch Consensus Prevention of Bedsores CBO - score on a scale of 0 to 3 points of mental state, neurological status, ability to move, nutritional status, way of eating, function of the anal sphincters and urethra, age, body temperature, medicines, comorbid diabetes.
8 points or more indicate a risk of bedsores.
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The first day of the therapy (one measure)
|
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Bedsores classification: the Torrance system
Time Frame: Change is being assessed after 36 days
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Assessment of the degree damage and color of tissue. 1°-the lowest degree of bedsore 5°- the highest degree of bedsore |
Change is being assessed after 36 days
|
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Measurement of bedsores size
Time Frame: Change is being assessed after 36 days
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Vertical and horizontal size of bedsores
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Change is being assessed after 36 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Photo of bedsores
Time Frame: On the first, 9, 18 and 36 day of therapy
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Visual image of bedsores
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On the first, 9, 18 and 36 day of therapy
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260.
- Thomas E, Vinodkumar S, Mathew S, Setia MS. A Study of the Factors Associated with Risk for Development of Pressure Ulcers: A Longitudinal Analysis. Indian J Dermatol. 2015 Nov-Dec;60(6):566-72. doi: 10.4103/0019-5154.169127.
- Rutteman B, Borremans K, Beckers J, Devleeschouwer E, Lampmann S, Corthouts I, Verlinde P. Aeromonas wound infection in a healthy boy, and wound healing with polarized light. JMM Case Rep. 2017 Oct 16;4(10):e005118. doi: 10.1099/jmmcr.0.005118. eCollection 2017 Oct.
- Oliveira PC, Pinheiro AL, de Castro IC, Reis JA Jr, Noia MP, Gurgel C, Teixeira Cangussu MC, Pedreira Ramalho LM. Evaluation of the effects of polarized light (lambda400-200 nm) on the healing of third-degree burns in induced diabetic and nondiabetic rats. Photomed Laser Surg. 2011 Sep;29(9):619-25. doi: 10.1089/pho.2010.2914. Epub 2011 Jun 1.
- Pinheiro AL, Meireles GC, Carvalho CM, de Barros Vieira AL, dos Santos JN, Ramalho LM. Biomodulative effects of polarized light on the healing of cutaneous wounds on nourished and undernourished Wistar rats. Photomed Laser Surg. 2006 Oct;24(5):616-24. doi: 10.1089/pho.2006.24.616.
- Ishmamet'ev II, Deriabin EI, Zharov VV, Ishmamet'ev IL, Tochilova ER. [Microcirculation changes after polarized polychromatic light use in preoperative period in cases of face cosmetic operations]. Stomatologiia (Mosk). 2008;87(6):38-40. Russian.
- Akilbekova D, Boddupalli A, Bratlie KM. The effect of polarized light on the organization of collagen secreted by fibroblasts. Lasers Med Sci. 2018 Apr;33(3):539-547. doi: 10.1007/s10103-017-2398-0. Epub 2017 Nov 30.
- Tada K, Ikeda K, Tomita K. Effect of polarized light emitting diode irradiation on wound healing. J Trauma. 2009 Nov;67(5):1073-9. doi: 10.1097/TA.0b013e318187ad02.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Piler
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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