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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Foot Ulcer
• Intervention / Treatment: Procedure: Dressing; Device: CC; Device: LG1; Device: LG2; Device: LG3

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Piauí
    • Parnaíba, Piauí, Brazil, 64202-020
      • Federal University of Piaui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CC + dressing; The group will receive placebo LASER application associated with Helianthus annuus oil dressing.	Procedure: Dressing; Application of Helianthus annuus oil dressing.; Device: CC; Application of placebo LASER.
Active Comparator: LG1 + dressing; The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.	Procedure: Dressing; Application of Helianthus annuus oil dressing.; Device: LG1; Application of LASER AsGa 904nm 10 J/cm².
Active Comparator: LG2 + dressing; The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.	Procedure: Dressing; Application of Helianthus annuus oil dressing.; Device: LG2; Application of LASER AsGa 904nm 8 J/cm².
Active Comparator: LG3 + dressing; The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.	Procedure: Dressing; Application of Helianthus annuus oil dressing.; Device: LG3; Application of LASER AsGa 904nm 4 J/cm².

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ulcer area	Measure of ulcer area change.	Before intervention starts, 5th and 10th week of intervention.
Change in complete ulcer healing	Change in the percentage of complete ulcer healing.	Before intervention starts, 5th and 10th week of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Blood glucose	Glycemic levels.	Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Temperature	Ulcer temperature.	Before intervention starts, 5th and 10th week of intervention.
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.

Collaborators and Investigators

• Sponsor: Federal University of Piaui

Publications and helpful links

General Publications

• Cardoso VS, de Souza Lima da Silveira PR, Dos Santos CM, da Rocha RB, Hazime FA. Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial. Contemp Clin Trials. 2021 Nov;110:106561. doi: 10.1016/j.cct.2021.106561. Epub 2021 Sep 4.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): August 18, 2021
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 17081119.1.0000.5214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No