Treatment of Bedsores With VIP Light

August 9, 2018 updated by: Jolanta Zwolińska, University of Rzeszow

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

Completed

Detailed Description

18 people were examined. In all subjects, were assessed the risk of developing bedsores according to the scale Dutch Consensus Prevention of Bedsores CBO. All bedsores were irradiated with a Bioptron lamp (20 sessions, twice a day). Photo and measurement of bedsores size and Torrance score, were made:on the first, 9, 18 and 36 day of therapy.

Study Type

Observational

Enrollment (Actual)

18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

nursing home residents

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
20 irradiations were performed twice a day. The exposure time was 10 minutes. Exposure was made at a distance of 10 cm.

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)
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)
Bedsores classification: the Torrance system
Time Frame: Change is being assessed after 36 days

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
Measurement of bedsores size
Time Frame: Change is being assessed after 36 days
Vertical and horizontal size of bedsores
Change is being assessed after 36 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photo of bedsores
Time Frame: On the first, 9, 18 and 36 day of therapy
Visual image of bedsores
On the first, 9, 18 and 36 day of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 6, 2016

Primary Completion (ACTUAL)

June 9, 2017

Study Completion (ACTUAL)

November 21, 2017

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (ACTUAL)

August 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

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)?

NO

IPD Plan Description

Lack of consent of participants due to difficult contact

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Light; Therapy; Bedsore

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