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

NCT03788642 | Completed

• 1 other identifier: Si475/2561
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Low Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Ulcer Healing Rate

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

  12 weeks

Secondary Outcomes (2)

• Time to ulcer healing

  time from date of randomisation to date of healing within the 12 month study period

• Clinical Success - Complications

  up to 12 months

Study Arms (2)

Control LED Shoe arm

ACTIVE COMPARATOR

Patients with DFU will wear LED shoe 30 minutes per day

Procedure: Control LED shoe arm

Laser Shoe arm

ACTIVE COMPARATOR

Patients with DFU will wear Laser shoe 30 minutes per day

Procedure: Laser Shoe arm

Interventions

Control LED shoe arm PROCEDURE

Patients with DFU will wear LED shoe 30 minutes once daily

Control LED Shoe arm

Laser Shoe arm PROCEDURE

Patients with DFU will wear Laser shoe 30 minutes once daily

Laser Shoe arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infected ulcer
• Fever
• HbA1C \> 15 %

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Nuttawut SERMSATHANASAWADI, MD, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: January 15, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

TH (1)