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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

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Foot Device: LG1 Device: LG2 Device: LG3 Device: CC Procedure: Dressing Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial
Actual Study Start Date : August 27, 2019
Estimated Primary Completion Date : August 18, 2020
Estimated Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: CC + dressing
The group will receive placebo LASER application associated with Helianthus annuus oil dressing.
Device: CC
Application of placebo LASER.

Procedure: Dressing
Application of Helianthus annuus oil 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.
Device: LG1
Application of LASER AsGa 904nm 10 J/cm².

Procedure: Dressing
Application of Helianthus annuus oil 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.
Device: LG2
Application of LASER AsGa 904nm 8 J/cm².

Procedure: Dressing
Application of Helianthus annuus oil 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.
Device: LG3
Application of LASER AsGa 904nm 4 J/cm².

Procedure: Dressing
Application of Helianthus annuus oil dressing.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246814


Locations
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Brazil
Federal University of Piaui Recruiting
Parnaíba, Piauí, Brazil, 64202-020
Contact: Vinicius S Cardoso, PhD    +55(86)99984-2919    vscfisio@ufpi.edu.br   
Sponsors and Collaborators
Federal University of Piaui
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Responsible Party: Vinicius Saura Cardoso, PhD Professor of the Graduate Program in Biomedical Sciences, Federal University of Piaui
ClinicalTrials.gov Identifier: NCT04246814    
Other Study ID Numbers: 17081119.1.0000.5214
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases