Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Wound Healing Disorder Clinical Trial

Official title:

Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446767
• Other study ID #: P.T REC/017/00482.
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: September 5, 2020

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 5, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Wound Healing Disorder

Intervention

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

Other:
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alaini	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Wound assessment	The wound surface area (ulcer size), lenghth and width will measured using Ruler technique	two months