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NCT03788642 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03788642
Other study ID # Si475/2561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date October 31, 2021

Study information
Verified date December 2021
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Control LED shoe arm
Patients with DFU will wear LED shoe 30 minutes once daily
• Laser Shoe arm
Patients with DFU will wear Laser shoe 30 minutes once daily

Locations
Country Name City State
Thailand Vascular Surgery, Siriraj Hospital, Mahidol University Bangkoknoi Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ulcer Healing Rate Healing rate of control and laser group will be reported at 12 weeks 12 weeks
Secondary 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. time from date of randomisation to date of healing within the 12 month study period
Secondary Clinical Success - Complications Incidence of complications related to the LLT shoe up to 12 months
See also
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Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
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