Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

NCT ID: NCT04446767

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-09-05

Brief Summary

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Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

Detailed Description

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Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.

Conditions

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Wound Healing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bioptron light therapy and medical care

bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

Group Type EXPERIMENTAL

polarized light

Intervention Type RADIATION

bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks

medical care

Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

Group Type ACTIVE_COMPARATOR

Medical Care

Intervention Type OTHER

Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

Interventions

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polarized light

bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks

Intervention Type RADIATION

Medical Care

Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

Intervention Type OTHER

Other Intervention Names

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bioptron light therapy

Eligibility Criteria

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Inclusion Criteria

1. The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
2. Cooperative and mentally stable patients .

Exclusion Criteria

1. Hepatic patients .
2. Uncontrolled hypertension .
3. Uncontrolled diabetic patients with HbA1c\>8.5% .
4. Neurological disorders .
5. Musculoskeletal disorders that interfere with program .
6. Previous history or any sign of DVT .
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mohamed Taha

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alaini

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Taha MM, El-Nagar MM, Elrefaey BH, Elkholy RM, Ali OI, Alkhamees N, Felaya EEE. Effect of Polarized Light Therapy (Bioptron) on Wound Healing and Microbiota in Diabetic Foot Ulcer: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Dec;40(12):792-799. doi: 10.1089/photob.2021.0175. Epub 2022 Oct 28.

Reference Type DERIVED
PMID: 36315226 (View on PubMed)

Other Identifiers

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P.T REC/017/00482.

Identifier Type: -

Identifier Source: org_study_id

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