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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2023
CompletedFebruary 22, 2024
February 1, 2024
2 years
January 22, 2020
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Wagner Classification
Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Blood glucose
Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Temperature
Before intervention starts, 5th and 10th week of intervention.
Short Form-36 Health Survey questionnaire
Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Study Arms (4)
CC + dressing
PLACEBO COMPARATORThe group will receive placebo LASER application associated with Helianthus annuus oil dressing.
LG1 + dressing
ACTIVE COMPARATORThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.
LG2 + dressing
ACTIVE COMPARATORThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.
LG3 + dressing
ACTIVE COMPARATORThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.
Interventions
Application of Helianthus annuus oil dressing.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 and over.
You may not qualify if:
- Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
- Patients with infected diabetic foot ulcers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Piaui
Parnaíba, Piauí, 64202-020, Brazil
Related Publications (2)
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.
PMID: 38805069DERIVEDCardoso 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.
PMID: 34487920DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Masking will be double-blind, the volunteer and outcome assessor will not be aware of the individual allocation of participants in the intervention groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Professor of the Graduate Program in Biomedical Sciences
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 29, 2020
Study Start
August 27, 2019
Primary Completion
August 18, 2021
Study Completion
August 18, 2023
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share