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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control LED Shoe arm | Active Comparator | Patients with DFU will wear LED shoe 30 minutes per day |
|
| Laser Shoe arm | Active Comparator | Patients with DFU will wear Laser shoe 30 minutes per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control LED shoe arm | Procedure | Patients with DFU will wear LED shoe 30 minutes once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Healing Rate | Healing rate of control and laser group will be reported at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ulcer healing | 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. | time from date of randomisation to date of healing within the 12 month study period |
| Clinical Success - Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuttawut SERMSATHANASAWADI, MD, PhD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Surgery, Siriraj Hospital, Mahidol University | Bangkoknoi | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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The randomised clinical trial with participants randomised1:1 to either
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| Laser Shoe arm | Procedure | Patients with DFU will wear Laser shoe 30 minutes once daily |
|
Incidence of complications related to the LLT shoe |
| up to 12 months |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |