NCT04246814

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

Completed NA Last updated 22 February 2024

What this trial tests

NA trial testing LG1 in Diabetic Foot Ulcer in 80 participants. Completed in 18 August 2023.

Timeline

27 August 2019

Primary endpoint
18 August 2021

18 August 2023

Quick facts

Lead sponsor	Federal University of Piaui
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	27 August 2019
Primary completion	18 August 2021
Estimated completion	18 August 2023
Sites	1 location across Brazil

Drugs / interventions tested

• LG1
• LG2
• LG3
• CC — full drug profile →
• Dressing

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

Federal University of Piaui

Who can join

Adults 18 to 79, any sex, with Diabetic Foot Ulcer or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial.
   Saura Cardoso V, de Souza Lima da Silveira PR, Dos Santos CM, Miranda MB, et al · · 2024 · cited 4× · PMID 38805069 · DOI 10.1007/s10103-024-04090-3
2. Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial.
   Cardoso VS, de Souza Lima da Silveira PR, Dos Santos CM, da Rocha RB, et al · · 2021 · cited 3× · PMID 34487920 · DOI 10.1016/j.cct.2021.106561