Comparison of the efficacy of hospital-based and home-use low-level laser therapy for treatment of diabetic foot ulcer : A pilot study
Phase 2
Recruiting
- Conditions
- Patients with diabetic foot ulcersDiabetic foot ulcer, Low level laser therapy
- Registration Number
- TCTR20230222014
- Lead Sponsor
- Prima Laser Therapy Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound area reduction Pretreatment and 14 days posttreatment Percentage wound area reduction
- Secondary Outcome Measures
Name Time Method 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