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Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy

NCT05071235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-22

No results posted yet for this study

Summary

Diabetic foot ulcers (DFU) are aggressive complications of diabetes mellitus (DM) and affect 25% of these patients. DFU are associated with a high risk of amputations and early mortality and significantly impact quality of life (QoL). The low-level laser therapy (LLLT) is an important approach for the treatment of DFU, however there is a lack of data on its influence on the QoL of patients with DFU. On the other hand, adherence to self-care is a factor closely related to QoL. Therefore, this study is justified by the need to understand the impact of LLLT on QoL and its relationship with self-care. Aim: To evaluate the quality of life of patients with diabetic foot ulcers treated with different doses of LLLT (GaAs) 904 nm and its association with aspects of adherence to self-care. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned to the groups: control LLLT placebo (CG), LLLT 904 nm 10 J/cm² (LG1), LLLT 904 nm 8 J/cm² (LG2) and LLLT 904 nm 4 J/cm² (LG3). QoL data, percentage of healing and pain will be assessed before the start of the intervention, in 10th week and after one month to the end of intervention, self-care will be assessed before the start of the intervention and at the end of intervention. Eighty participants with DFU will be recruited who will receive intervention twice a week for up to 20 visits (10 weeks).

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot

Interventions

DEVICE

LG1 (LLLT group 1)

Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm².

DEVICE

LG2 (LLLT group 2)

Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm².

DEVICE

LG3 (LLLT group 3)

Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm².

DEVICE

CG (control group)

Application of placebo LLLT (low-level laser therapy), that is, with the device turned off.

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
2021-11-30
Completion
2022-11-30

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 NCT05071235 on ClinicalTrials.gov