Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246814
• Other study ID #: 17081119.1.0000.5214
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: August 18, 2023

Study information

• Verified date: February 2024
• Source: Federal University of Piaui
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.

Description:

All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus patients with diabetic foot ulcers;
• Patients aged 18 and over.

Exclusion Criteria:

• Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
• Patients with infected diabetic foot ulcers.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• LG1
Application of LASER AsGa 904nm 10 J/cm².
• LG2
Application of LASER AsGa 904nm 8 J/cm².
• LG3
Application of LASER AsGa 904nm 4 J/cm².
• CC
Application of placebo LASER.

Procedure:
• Dressing
Application of Helianthus annuus oil dressing.

Locations

Country	Name	City	State
Brazil	Federal University of Piaui	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Piaui

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ulcer area	Measure of ulcer area change.	Before intervention starts, 5th and 10th week of intervention.
Primary	Change in complete ulcer healing	Change in the percentage of complete ulcer healing.	Before intervention starts, 5th and 10th week of intervention.
Secondary	Wagner Classification	Ulcer categorization according to Wagner Classification.	Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Secondary	Blood glucose	Glycemic levels.	Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Secondary	Temperature	Ulcer temperature.	Before intervention starts, 5th and 10th week of intervention.
Secondary	Short Form-36 Health Survey questionnaire	The Short Form-36 Health Survey questionnaire (SF 36) assesses quality of life and consists of 36 questions, covering 8 domains. This questionnaire has a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 to the best health status.	Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.