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Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788642
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and a half to recieve the placebo (LED).

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Procedure: Control LED shoe arm Procedure: Laser Shoe arm Not Applicable

Detailed Description:
Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to see whether LLLT shoe helps with healing compare with placebo (LED shoe).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The randomised clinical trial with participants randomised1:1 to either

  • Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily
  • Laser group : Patients will wear Laser shoe 30 minutes once daily
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control LED Shoe arm
Patients with DFU will wear LED shoe 30 minutes per day
Procedure: Control LED shoe arm
Patients with DFU will wear LED shoe 30 minutes once daily

Active Comparator: Laser Shoe arm
Patients with DFU will wear Laser shoe 30 minutes per day
Procedure: Laser Shoe arm
Patients with DFU will wear Laser shoe 30 minutes once daily




Primary Outcome Measures :
  1. Ulcer Healing Rate [ Time Frame: 12 weeks ]
    Healing rate of control and laser group will be reported at 12 weeks


Secondary Outcome Measures :
  1. Time to ulcer healing [ Time Frame: time from date of randomisation to date of healing within the 12 month study period ]
    For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized leg in the absence of a scab (eschar) with no dressing required.

  2. Clinical Success - Complications [ Time Frame: up to 12 months ]
    Incidence of complications related to the LLT shoe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic diabetic foot ulcer
  • Ankle brachial index ≥ 0.4
  • Toe pressure brachial index ≥ 0.3
  • Transcutaneous oxygen measurement (TCOM) ≥ 40 mmHg
  • Ulcer size less than 25 cm2

Exclusion Criteria:

  • Infected ulcer
  • Fever
  • HbA1C > 15 %

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): NCT03788642


Contacts
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Contact: Nuttawut SERMSATHANASAWADI, MD, PhD +66851118278 nuttawut@gmail.com

Locations
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Thailand
Vascular Surgery, Siriraj Hospital, Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Nuttawut Sermsathanasawadi, MD., Ph.D    +6624198021    nutttawut@gmail.com   
Principal Investigator: Nuttawut Sermsathanasawadi, MD., Ph.D         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nuttawut SERMSATHANASAWADI, MD, PhD Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03788642    
Other Study ID Numbers: Si475/2561
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Diabetic Foot Ulcer
Low Level Laser Therapy
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