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

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Control LED shoe arm
Laser Shoe arm
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Low Level Laser Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 %

Sites / Locations

  • Vascular Surgery, Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control LED Shoe arm

Laser Shoe arm

Arm Description

Patients with DFU will wear LED shoe 30 minutes per day

Patients with DFU will wear Laser shoe 30 minutes per day

Outcomes

Primary Outcome Measures

Ulcer Healing Rate
Healing rate of control and laser group will be reported at 12 weeks

Secondary Outcome Measures

Time to ulcer healing
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.
Clinical Success - Complications
Incidence of complications related to the LLT shoe

Full Information

First Posted
December 25, 2018
Last Updated
December 16, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03788642
Brief Title
Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Official Title
Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic Foot Ulcer, Low Level Laser Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control LED Shoe arm
Arm Type
Active Comparator
Arm Description
Patients with DFU will wear LED shoe 30 minutes per day
Arm Title
Laser Shoe arm
Arm Type
Active Comparator
Arm Description
Patients with DFU will wear Laser shoe 30 minutes per day
Intervention Type
Procedure
Intervention Name(s)
Control LED shoe arm
Intervention Description
Patients with DFU will wear LED shoe 30 minutes once daily
Intervention Type
Procedure
Intervention Name(s)
Laser Shoe arm
Intervention Description
Patients with DFU will wear Laser shoe 30 minutes once daily
Primary Outcome Measure Information:
Title
Ulcer Healing Rate
Description
Healing rate of control and laser group will be reported at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to ulcer healing
Description
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 Frame
time from date of randomisation to date of healing within the 12 month study period
Title
Clinical Success - Complications
Description
Incidence of complications related to the LLT shoe
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 %
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuttawut SERMSATHANASAWADI, MD, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Surgery, Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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