NCT04446767

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

May 28, 2020

Last Update Submit

February 28, 2021

Conditions

Wound Healing Disorder

Keywords

diabetesfoot ulcerpolarized light;wound healing

Outcome Measures

Primary Outcomes (2)

  • Histologic evaluation:

    Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment

    two months

  • Wound assessment

    The wound surface area (ulcer size), lenghth and width will measured using Ruler technique

    two months

Study Arms (2)

Bioptron light therapy and medical care

EXPERIMENTAL

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

Radiation: polarized light

medical care

ACTIVE COMPARATOR

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

Other: Medical Care

Interventions

polarized lightRADIATION

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

Also known as: bioptron light therapy
Bioptron light therapy and medical care
Medical CareOTHER

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

medical care

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hepatic patients .
  • Uncontrolled hypertension .
  • Uncontrolled diabetic patients with HbA1c\>8.5% .
  • Neurological disorders .
  • Musculoskeletal disorders that interfere with program .
  • Previous history or any sign of DVT .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 36315226DERIVED

MeSH Terms

Conditions

Diabetes MellitusFoot Ulcer

Interventions

Microscopy, Polarization

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 25, 2020

Study Start

June 30, 2020

Primary Completion

August 30, 2020

Study Completion

September 5, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)