Light; Therapy; Bedsore Clinical Trial
Official title:
The Effect of VIP Light on Healing Bedsores Process
| NCT number | NCT03627702 |
| Other study ID # | Piler |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 6, 2016 |
| Est. completion date | November 21, 2017 |
| Verified date | August 2018 |
| Source | University of Rzeszow |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | November 21, 2017 |
| Est. primary completion date | June 9, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Rzeszow |
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. — View Citation
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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. — View Citation
Oliveira PC, Pinheiro AL, de Castro IC, Reis JA Jr, Noia MP, Gurgel C, Teixeira Cangussú MC, Pedreira Ramalho LM. Evaluation of the effects of polarized light (?400-200 nm) on the healing of third-degree burns in induced diabetic and nondiabetic rats. Pho — View Citation
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. — View Citation
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. eCollectio — View Citation
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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | scale Dutch Consensus Prevention of Bedsores CBO | 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. | The first day of the therapy (one measure) | |
| Primary | Bedsores classification: the Torrance system | 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 | |
| Primary | Measurement of bedsores size | Vertical and horizontal size of bedsores | Change is being assessed after 36 days | |
| Secondary | Photo of bedsores | Visual image of bedsores | On the first, 9, 18 and 36 day of therapy |