Skip to content

Comparison of the efficacy of hospital-based and home-use low-level laser therapy for treatment of diabetic foot ulcer : A pilot study

Comparison of the efficacy of hospital-based and home-use low-level laser therapy for treatment of diabetic foot ulcer : A pilot study

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230222014
Enrollment
20
Registered
2023-02-22
Start date
2023-03-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with diabetic foot ulcers Diabetic foot ulcer, Low level laser therapy

Interventions

Apply home-use low-level laser therapy (L-MAT, Prima Laser Therapy Co., Ltd., Thailand) (660 and 850 nm, frequency 4 Hz, fluence 4 J/cm2) for 30 minutes, once daily for 14 days, with additional standa
Experimental Device,Active Comparator Device
Home-use low-level laser therapy,Hospital-based laser therapy

Sponsors

Prima Laser Therapy Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. has been diagnosed with diabetes and has had a diabetic foot ulcer at least for four weeks 2. less than 12 square meters in wound area 3. admitted as an inpatient for two weeks 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Wounds with Wagner classifications of 3 or higher 2. Wound with a difficult area for laser approach 3. Contraindications for Laser Therapy 4. Ankle pressure < 50 mmHg 5. Toe pressure < 30 mmHg 6. ABI < 0.4 7. Has a sign of critical limb ischemia evaluated by a physician 8. Refuse to join or continue the research

Design outcomes

Primary

MeasureTime frame
Wound area reduction Pretreatment and 14 days posttreatment Percentage wound area reduction

Secondary

MeasureTime frame
Wound Assessment Pretreatment and 14 days posttreatment Pressure Ulcer Scale for Healing,Ankle-Brachial Index Pretreatment and 14 days posttreatment Ankle-Brachial Index,Ankle pressure Pretreatment and 14 days posttreatment Ankle pressure,Toe pressure Pretreatment and 14 days posttreatment Toe pressure,Transcutaneous oximetry Pretreatment and 14 days posttreatment Transcutaneous oximetry

Countries

Thailand

Contacts

Public ContactPeerada Eurcherdkul

Faculty of medicine Ramathibodi, Mahidol university

eurpeerada@gmail.com0922720652

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026