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

NCT04246814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot

Interventions

DEVICE

LG1

Application of LASER AsGa 904nm 10 J/cm².

DEVICE

LG2

Application of LASER AsGa 904nm 8 J/cm².

DEVICE

LG3

Application of LASER AsGa 904nm 4 J/cm².

DEVICE

CC

Application of placebo LASER.

PROCEDURE

Dressing

Application of Helianthus annuus oil dressing.

Sponsors & Collaborators

  • Federal University of Piaui

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2021-08-18
Completion
2023-08-18

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246814 on ClinicalTrials.gov