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

Mahidol University

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: Control LED shoe arm; Procedure: Laser Shoe arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03788642

Si475/2561

Details and patient eligibility

About

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).

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 %

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Control LED Shoe arm

Active Comparator group

Description:

Patients with DFU will wear LED shoe 30 minutes per day

Treatment:

Procedure: Control LED shoe arm

Laser Shoe arm

Active Comparator group

Description:

Patients with DFU will wear Laser shoe 30 minutes per day

Treatment:

Procedure: Laser Shoe arm