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Completed

NCT Number: NCT03788642

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).

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

Control LED shoe arm

Procedure

Patients with DFU will wear LED shoe 30 minutes once daily

Laser Shoe arm

Procedure

Patients with DFU will wear Laser shoe 30 minutes once daily

Primary outcomes

  1. Ulcer Healing Rate

    Time frame: 12 weeks

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

Secondary outcomes

  1. 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.

  2. Clinical Success - Complications

    Time frame: up to 12 months

    Incidence of complications related to the LLT shoe

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 27, 2018
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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