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

NCT ID: NCT04246814

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-27
• Study Completion Date: 2023-08-18

Brief 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.

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.

Conditions

Diabetic Foot Ulcer; Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CC + dressing

The group will receive placebo LASER application associated with Helianthus annuus oil dressing.

Group Type: PLACEBO_COMPARATOR

CC

Intervention Type: DEVICE

Application of placebo LASER.

Dressing

Intervention Type: PROCEDURE

Application of Helianthus annuus oil dressing.

LG1 + dressing

The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.

Group Type: ACTIVE_COMPARATOR

LG1

Intervention Type: DEVICE

Application of LASER AsGa 904nm 10 J/cm².

Dressing

Intervention Type: PROCEDURE

Application of Helianthus annuus oil dressing.

LG2 + dressing

The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.

Group Type: ACTIVE_COMPARATOR

LG2

Intervention Type: DEVICE

Application of LASER AsGa 904nm 8 J/cm².

Dressing

Intervention Type: PROCEDURE

Application of Helianthus annuus oil dressing.

LG3 + dressing

The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.

Group Type: ACTIVE_COMPARATOR

LG3

Intervention Type: DEVICE

Application of LASER AsGa 904nm 4 J/cm².

Dressing

Intervention Type: PROCEDURE

Application of Helianthus annuus oil dressing.

Interventions

LG1

Application of LASER AsGa 904nm 10 J/cm².

Intervention Type: DEVICE

LG2

Application of LASER AsGa 904nm 8 J/cm².

Intervention Type: DEVICE

LG3

Application of LASER AsGa 904nm 4 J/cm².

Intervention Type: DEVICE

CC

Application of placebo LASER.

Intervention Type: DEVICE

Dressing

Application of Helianthus annuus oil dressing.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Piaui

OTHER

Sponsor Role: lead

Responsible Party

Vinicius Saura Cardoso

PhD Professor of the Graduate Program in Biomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Piaui

Parnaíba, Piauí, Brazil

Countries

Brazil

References

Saura Cardoso V, de Souza Lima da Silveira PR, Dos Santos CM, Miranda MB, Silva Barros AC, Veloso LC, Magalhaes AT, da Rocha RB, Hazime FA. Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial. Lasers Med Sci. 2024 May 28;39(1):142. doi: 10.1007/s10103-024-04090-3.

Reference Type: DERIVED

PMID: 38805069 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34487920 (View on PubMed)

Other Identifiers

17081119.1.0000.5214

Identifier Type: -

Identifier Source: org_study_id