Diabetic Foot UlcerNCT03788642
Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
A study testing Laser Shoe arm in people with Diabetic Foot Ulcer, run by Mahidol University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Laser Shoe arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jan 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infected ulcer
- Fever
- HbA1C > 15 %
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
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).
Read the 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).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Control LED shoe arm, Laser Shoe arm
- Keywords
- Diabetic Foot Ulcer, Low Level Laser Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control LED shoe armProcedure or surgery
Patients with DFU will wear LED shoe 30 minutes once daily
Laser Shoe armProcedure or surgery
Patients with DFU will wear Laser shoe 30 minutes once daily
| Study group | Role | What they receive |
|---|---|---|
| Control LED Shoe arm | Active comparator | Patients with DFU will wear LED shoe 30 minutes per day Receives: Procedure: Control LED shoe arm |
| Laser Shoe arm | Active comparator | Patients with DFU will wear Laser shoe 30 minutes per day Receives: Procedure: Laser Shoe arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing Rate
Healing rate of control and laser group will be reported at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: time from date of randomisation to date of healing within the 12 month study period
Clinical Success - Complications
Incidence of complications related to the LLT shoe
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start15 Jan 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuttawut SERMSATHANASAWADI, MD, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788642
- Sponsor's protocol ID
- Si475/2561
- Status last verified
- Dec 2021
- First submitted
- 25 Dec 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03788642
- Acronym / sponsor ID
- Si475/2561
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control LED Shoe arm | Active comparator | Procedure: Control LED shoe armPatients with DFU will wear LED shoe 30 minutes per day |
| Laser Shoe arm | Active comparator | Procedure: Laser Shoe armPatients with DFU will wear Laser shoe 30 minutes per day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Infected ulcer
- Fever
- HbA1C > 15 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control LED shoe armPatients with DFU will wear LED shoe 30 minutes once daily | Procedure or surgery | Control LED Shoe arm |
| Laser Shoe armPatients with DFU will wear Laser shoe 30 minutes once daily | Procedure or surgery | Laser Shoe arm |
Primary outcome
Ulcer Healing Rate
Time frame: 12 weeks
Healing rate of control and laser group will be reported at 12 weeks
2 secondary outcomes
Time to ulcer healing
Time frame: time from date of randomisation to date of healing within the 12 month study period
Clinical Success - Complications
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuttawut SERMSATHANASAWADI, MD, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Shoe arm in people with Diabetic Foot Ulcer, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Healing Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.