Effect of laser on Diabetic Foot: randomized clinical trial

Not Applicable

Recruiting

• Conditions: Diabetic Foot; C18.452.394.750

• Registration Number: RBR-9vv5rsw
• Lead Sponsor: Faculdade de Enfermagem - Universidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participants with diabetes mellitus; both genders; aged 18 or over; foot wound

Exclusion Criteria

Lupus; pyoderma gangrenosum; Steve Johnson Syndrome.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in wound area size from initiation of treatment to end of follow-up period, 12 weeks. The difference in the area of the wound will be evaluated through the weekly photographs, the photos will be inserted in the ImageJ software that calculates the area in square centimeters.

Secondary Outcome Measures

Name	Time	Method
Wound area reduction will be measured in square centimeters (cm2), length x width of the area will be measured in cm2 and area change calculated in percentage (%). Wound closure will be expressed in %, calculated by the following mathematical formula, called the ulcer contraction index (ICU):<br><br>ICU= Initial wound area- (Daily area)(Initial area) x 100%<br>;Analysis of the expression of inflammatory cytokines using the polymerase chain reaction (PCR) technique and enzyme-linked immunosorbent assay (ELISA);The appearance of tissue quality in the wound bed (granulation tissue), decrease in exudate, appearance and contraction of edges will be assessed using the Bates-Jansen Wound Assessment Tool.