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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT03788642

Collaborator

(none)

Enrollment

Location

Arms

33.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Procedure: Control LED shoe arm Procedure: Laser Shoe arm	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 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 dailyThe 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 :

Jan 15, 2019

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to ulcer healing [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.
Clinical Success - Complications [up to 12 months]
Incidence of complications related to the LLT shoe

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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 %

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Surgery, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahidol University

ClinicalTrials.gov Identifier:

NCT03788642

Other Study ID Numbers:

Si475/2561

First Posted:

Dec 27, 2018

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahidol University

Diabetic Foot Ulcer

Low Level Laser Therapy

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Ulcer

Study Results

No Results Posted as of Dec 17, 2021