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

December 16, 2021 updated by: Mahidol University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Vascular Surgery, Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 %

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer Healing Rate
Time Frame: 12 weeks
Healing rate of control and laser group will be reported at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
time from date of randomisation to date of healing within the 12 month study period
Clinical Success - Complications
Time Frame: up to 12 months
Incidence of complications related to the LLT shoe
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Nuttawut SERMSATHANASAWADI, MD, PhD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si475/2561

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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