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

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ClinicalTrials.gov Identifier: NCT04246814
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Vinicius Saura Cardoso, Federal University of Piaui

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 29, 2020
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE August 27, 2019
Estimated Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Change in the ulcer area [ Time Frame: Before intervention starts, 5th and 10th week of intervention. ]
    Measure of ulcer area change.
  • Change in complete ulcer healing [ Time Frame: Before intervention starts, 5th and 10th week of intervention. ]
    Change in the percentage of complete ulcer healing.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • 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.
  • Blood glucose [ Time Frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month. ]
    Glycemic levels.
  • Temperature [ Time Frame: Before intervention starts, 5th and 10th week of intervention. ]
    Ulcer temperature.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers
Official Title  ICMJE Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot Ulcer
  • Diabetic Foot
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: CC + dressing
    The group will receive placebo LASER application associated with Helianthus annuus oil dressing.
    Interventions:
    • Device: CC
    • Procedure: Dressing
  • Active Comparator: LG1 + dressing
    The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.
    Interventions:
    • Device: LG1
    • Procedure: Dressing
  • Active Comparator: LG2 + dressing
    The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.
    Interventions:
    • Device: LG2
    • Procedure: Dressing
  • Active Comparator: LG3 + dressing
    The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.
    Interventions:
    • Device: LG3
    • Procedure: Dressing
Publications * Cardoso VS, de Souza Lima da Silveira PR, Dos Santos CM, da Rocha RB, Hazime FA. Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial. Contemp Clin Trials. 2021 Sep 3:106561. doi: 10.1016/j.cct.2021.106561. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 18, 2020
Estimated Primary Completion Date August 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04246814
Other Study ID Numbers  ICMJE 17081119.1.0000.5214
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vinicius Saura Cardoso, Federal University of Piaui
Study Sponsor  ICMJE Federal University of Piaui
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Piaui
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP