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NCT Number: NCT04246814

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Piaui

Parnaíba, Piauí, 64202-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LG1

Device

Application of LASER AsGa 904nm 10 J/cm².

LG2

Device

Application of LASER AsGa 904nm 8 J/cm².

LG3

Device

Application of LASER AsGa 904nm 4 J/cm².

CC

Device

Application of placebo LASER.

Dressing

Procedure

Application of Helianthus annuus oil dressing.

Primary outcomes

  1. Change in the ulcer area

    Time frame: Before intervention starts, 5th and 10th week of intervention.

    Measure of ulcer area change.

  2. Change in complete ulcer healing

    Time frame: Before intervention starts, 5th and 10th week of intervention.

    Change in the percentage of complete ulcer healing.

Secondary outcomes

  1. Wagner Classification

    Time frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.

    Ulcer categorization according to Wagner Classification.

  2. Blood glucose

    Time frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.

    Glycemic levels.

  3. Temperature

    Time frame: Before intervention starts, 5th and 10th week of intervention.

    Ulcer temperature.

  4. Short Form-36 Health Survey questionnaire

    Time frame: Before 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.

Sponsors and collaborators

Lead sponsor

Federal University of Piaui

Other

Registry information

Official study title

Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jan 29, 2020
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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