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Completed

NCT Number: NCT04446767

Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

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

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Key information

Conditions

Wound Healing Disorder Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alaini

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 .

Treatment and study plan

polarized light

Radiation

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

Other names: bioptron light therapy

Medical Care

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

Primary outcomes

  1. Histologic evaluation:

    Time frame: two months

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

  2. Wound assessment

    Time frame: two months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Princess Nourah Bint Abdulrahman University

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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