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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04246814
Enrollment
80
Registered
2020-01-29
Start date
2019-08-27
Completion date
2023-08-18
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer, Diabetic Foot

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.

Interventions

DEVICELG1

Application of LASER AsGa 904nm 10 J/cm².

DEVICELG2

Application of LASER AsGa 904nm 8 J/cm².

DEVICELG3

Application of LASER AsGa 904nm 4 J/cm².

DEVICECC

Application of placebo LASER.

PROCEDUREDressing

Application of Helianthus annuus oil dressing.

Sponsors

Federal University of Piaui
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Masking will be double-blind, the volunteer and outcome assessor will not be aware of the individual allocation of participants in the intervention groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the ulcer areaBefore intervention starts, 5th and 10th week of intervention.Measure of ulcer area change.
Change in complete ulcer healingBefore intervention starts, 5th and 10th week of intervention.Change in the percentage of complete ulcer healing.

Secondary

MeasureTime frameDescription
Wagner ClassificationBefore intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.Ulcer categorization according to Wagner Classification.
Blood glucoseBefore intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.Glycemic levels.
TemperatureBefore intervention starts, 5th and 10th week of intervention.Ulcer temperature.
Short Form-36 Health Survey questionnaireBefore intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.The Short Form-36 Health Survey questionnaire (SF 36) assesses quality of life and consists of 36 questions, covering 8 domains. This questionnaire has a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 to the best health status.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026