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

NCT ID: NCT03788642

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-10-31

Brief Summary

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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

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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).

Conditions

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Diabetic Foot Ulcer

Keywords

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Diabetic Foot Ulcer Low Level Laser Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control LED Shoe arm

Patients with DFU will wear LED shoe 30 minutes per day

Group Type ACTIVE_COMPARATOR

Control LED shoe arm

Intervention Type PROCEDURE

Patients with DFU will wear LED shoe 30 minutes once daily

Laser Shoe arm

Patients with DFU will wear Laser shoe 30 minutes per day

Group Type ACTIVE_COMPARATOR

Laser Shoe arm

Intervention Type PROCEDURE

Patients with DFU will wear Laser shoe 30 minutes once daily

Interventions

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Control LED shoe arm

Patients with DFU will wear LED shoe 30 minutes once daily

Intervention Type PROCEDURE

Laser Shoe arm

Patients with DFU will wear Laser shoe 30 minutes once daily

Intervention Type PROCEDURE

Eligibility Criteria

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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 %
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuttawut SERMSATHANASAWADI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si475/2561

Identifier Type: -

Identifier Source: org_study_id