Diabetic Foot Ulcer (DFU)NCT06670417
Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
A study testing Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light, Buerger Allen exercise and Regular wound care in people with Diabetic Foot Ulcer (DFU), run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light, Buerger Allen exercise and Regular wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 30 Dec 2025
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index of 25-34.9 kg/m2.
- Glycated hemoglobin (HbA1c) \>7 %.
- ABP index absolute normal (1-1.3)
- Patient with polyneuropathy.
- Patient suffer from diabetes more than 5 years.
- Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.
Who cannot join
- Patients with history of hypo- hyperglycemic coma.
- Uncontrolled cardiovascular complications.
- Malignancy, Anemia, Hemorrhagic diseases.
- Cardiac peace maker.
- Deep venous thrombosis.
- Osteomyelitis.
- Patients with Monckeberg sclerosis.
- Photosensitivity to laser.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy
Giza, Dokki, 11432
Hend Abdel Lecturer, 002 1115507195, Drhendpt@cu.edu.eg
About this study
The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?
After clinical assessment patients will be randomly allocated into three groups equal in number:
Read more
Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light, Buerger Allen exercise, Regular wound care
- Keywords
- Low level laser, Diabetic Foot Ulcer, Blood glucose level
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser lightDevice
Low level laser therapy watch:
The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light. It provides 18 individual laser beams used for extravascular blood irradiation (transcutaneous) through radial and ulnar vessels at the wrist site.
Buerger Allen exerciseOther
Procedure-Keep the Buerger Allen exercise board on the cot. Elevate the lower extremities to an angle of 45 to 90 degree with the help of exercise board. Provided support to the lower extremities to maintain the position. Make the subject to maintain the same position in the same manner until the skin blanches (appears dead white). Lower the feet and the legs below the level of the rest of the body until redness appears (care should be taken that there is no pressure against the back of the knees). Place the legs flat on the bed for a few minutes. Ask the subjects to sit in a relaxed position while each foot is flexed and extended then inverted and everted for 3 minutes till the feet turns entirely pink. Ask the subject to rotate the feet in all the direction. Make the subject to lie quietly for 5 minutes, keeping legs warm with a blanket
Regular wound careOther
Regular wound care and dressing to the wound and ulcer
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch dev | Experimental | Not described Receives: Device: Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light |
| B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with | Experimental | Not described Receives: Other: Buerger Allen exercise |
| (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua | Experimental | Not described Receives: Other: Regular wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound surface area
Measured: From enrollment to the end of treatment at 2 weeks
Glycated hemoglobin HbA1c
Measured: From enrollment to the end of treatment at 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba afifi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670417
- Sponsor's protocol ID
- P.T.REC/012/004287
- Status last verified
- Dec 2023
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06670417
- Acronym / sponsor ID
- P.T.REC/012/004287
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Low level laser, Diabetic Foot Ulcer, Blood glucose level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Nov 2024 (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 goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?
After clinical assessment patients will be randomly allocated into three groups equal in number:
Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch dev | Experimental | Device: Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light |
| B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with | Experimental | Other: Buerger Allen exercise |
| (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua | Experimental | Other: Regular wound care |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index of 25-34.9 kg/m2.
- Glycated hemoglobin (HbA1c) \>7 %.
- ABP index absolute normal (1-1.3)
- Patient with polyneuropathy.
- Patient suffer from diabetes more than 5 years.
Key exclusion criteria (8 listed)
- Patients with history of hypo- hyperglycemic coma.
- Uncontrolled cardiovascular complications.
- Malignancy, Anemia, Hemorrhagic diseases.
- Cardiac peace maker.
- Deep venous thrombosis.
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 |
|---|---|---|
| Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser lightLow level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light. It provides 18 individual laser beams used for extravascular blood irradiation (transcutaneous) through radial and ulnar vessels at the wrist site. | Device | Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch dev |
| Buerger Allen exerciseProcedure-Keep the Buerger Allen exercise board on the cot. Elevate the lower extremities to an angle of 45 to 90 degree with the help of exercise board. Provided support to the lower extremities to maintain the position. Make the subject to maintain the same position in the same manner until the skin blanches (appears dead white). Lower the feet and the legs below the level of the rest of the body until redness appears (care should be taken that there is no pressure against the back of the knees). Place the legs flat on the bed for a few minutes. Ask the subjects to sit in a relaxed position while each foot is flexed and extended then inverted and everted for 3 minutes till the feet turns entirely pink. Ask the subject to rotate the feet in all the direction. Make the subject to lie quietly for 5 minutes, keeping legs warm with a blanket | Other | B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with |
| Regular wound careRegular wound care and dressing to the wound and ulcer | Other | (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua |
Primary outcome
wound surface area
Time frame: From enrollment to the end of treatment at 2 weeks
Glycated hemoglobin HbA1c
Time frame: From enrollment to the end of treatment at 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light, Buerger Allen exercise and Regular wound care in people with Diabetic Foot Ulcer (DFU), run by Cairo University at 1 site in Egypt.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Nov 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hebatullah Emad lecturer Assistant (002 1066103900, hebaemad2005@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound surface area (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 2 primary outcomes in all. 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 5 Nov 2024.