Diabetic Foot Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, Low Level Laser Therapy
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).
Detailed 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).
Interventions
PROCEDUREControl LED shoe arm
Patients with DFU will wear LED shoe 30 minutes once daily
PROCEDURELaser Shoe arm
Patients with DFU will wear Laser shoe 30 minutes once daily
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Healing Rate | 12 weeks | Healing rate of control and laser group will be reported at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ulcer healing | 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. |
| Clinical Success - Complications | up to 12 months | Incidence of complications related to the LLT shoe |
Countries
Thailand
Outcome results
None listed