Neuropathic Foot UlcerNCT06703762
Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer
A study testing He-Ne low level laser (LLL) and Conventional traditional treatment in people with Neuropathic Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Neuropathic Foot Ulcer
- What is being tested?
- He-Ne low level laser (LLL) and Conventional traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient will be diagnosed with neuropathic foot ulcer.
- All patient diagnosed as type II Diabetes Mellitus.
- Wound size a 6-12 cm2.
- Diabetic ulcers will be in grade 2 and 3 (Partial thickness skin loss involving epidermis and or dermis (superficial, abrasion, blister, and / or full thickness skin loss damage ore necrosis of subcutaneous tissue may extend down to but not through underlying fascia.
Who cannot join
- Presence of osteomyelitis.
- Patients associated with critical illness who needs intensive care.
- Patients who suffer from cellulitis.
- Patients who suffer from nerve injury.
- Pregnancy.
- Smokers
Show all 10Show fewer
- Malignant diseases
- Use of immunosuppressive drugs
- Phenytoin, cyclosporine, calcium channel blockers, etc.
- Patients who not have burn or ulcer or trauma in this area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hussein Gamal Hussein Mogahed, PhD contact
Egypt1 site
Cairo University
Giza
Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc, 01006400237, fatmaabdalsadek36@gmail.com
About this study
The aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer.
Read the detailed description
Wound healing is a complex, interactive, and integrative event, involving cellular and chemotactic activity with release of chemical mediators associated with vascular responses and cell proliferation. It consists in a sequence of events leading to the closure of dermal injuries. The repair follows steps of inflammation, re-epithelization, wound contraction, and matrix remodeling. The healing process can be influenced by various local and systemic factors.
The ulcer treatment in the diabetic foot requires a multidisciplinary approach, including revascularization and surgical procedures, as well as the infection treatment, physiotherapeutic rehabilitation with electric phototherapeutic resources to control edema, pain, metabolic disorders, tissue malnutrition, co morbidities, precise treatment of the wound and biomechanics' decompression that will help in amputation prevention.
Biophotomodulation in the form of Low level laser (LLL) irradiation can promote cell migration and cell proliferation by stimulating mitochondrial activity and maintaining viability without causing damage to the wounded cells.
The usage of LLLT presents itself as being a new therapeutic proposal, seeking the cure of these injuries, the improvement on the quality of life of the affected individuals, as well as the reduction of the costs of the treatment in the health system, this study aims to identify the effects of low-level laser therapy on neuropathic foot ulcer healing and the effect of LLL on the hyperglycemic-induced inflammatory response in IL-6 and sought to identify which pathway it might achieve this effect.
- Conditions
- Neuropathic Foot Ulcer
- Being tested
- He-Ne low level laser (LLL), Conventional traditional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
He-Ne low level laser (LLL)Other
Patients in the experimental group will receive treatment with LLLT. The ulcer bed will be irradiated locally with red light (660 nm). The ulcer size and its depth will be used as the basis to calculate the duration of exposure needed to deliver 3-10 J/cm² for 15 to 20 minutes. The application will take place in 3 sessions per week for 4 weeks. Each patient will be asked to lie in a supine position with the ulcer easily exposed to the laser beam, and they will be instructed to wear laser glasses and avoid looking directly at the beam until the end of the session.
Conventional traditional treatmentOther
All patients in both the groups will receive the required, conventional treatments of diabetic wound care, including dressing, antibiotics, controlling diabetes, cholesterol, and blood pressure along with aggressive drug treatment and wound debridement when needed.
| Study group | Role | What they receive |
|---|---|---|
| He-Ne low level laser (LLL) + Conventional traditional treatment | Experimental | It will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive He-Ne LLL for chronic neuropathic foot ulcer with pulsed wave form, visible ray, wave length of 632.8 nm, peak potency of 30 mW, (Laser -HTM). The application time will be 80 (4 J/cm2) seconds. The application will be 3 sessions /week for 4 weeks on the sole of the foot + Conventional traditional treatment. Receives: Other: He-Ne low level laser (LLL); Other: Conventional traditional treatment |
| Conventional traditional treatment | Active comparator | It will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive conventional traditional treatment (regular sharp debridement of calluses surrounding the ulcer, use of walking or total-contact casts for off-loading and regular moist dressing patients will be instructed to use only sodium chloride (saline solution 0.9%), regarding the daily asepsis of the ulcer). Receives: Other: Conventional traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Ulcer Length
The length of the ulcer can be precisely measured using the Imito Measure application. By utilizing a specialized marker for calibration, the app allows users to trace the ulcer's longest dimension. After capturing an image, the app calculates the length automatically, providing an accurate measurement.
Measured: 4 weeks
Measurement of Ulcer Width
The width of the ulcer is measured in a similar manner using the Imito Measure app. Users trace the widest part of the wound, and the app, after calibration with the marker, determines the exact width from the captured photo.
Measured: 4 weeks
Measurement of Ulcer Area
The area of the ulcer is calculated by encircling the entire wound boundary using the Imito Measure application. The app uses the calibration marker to ensure accuracy and then automatically computes the total wound area. The Imito Measure application has been scientifically validated as a reliable alternative to traditional wound measurement methods, such as wound rulers.
Measured: 4 weeks
Measurement of volume of the ulcer
It can be measured by using Syringe method by injecting saline into the wound until it overflows from the wound and measure the amount of saline.
Measured: 4 weeks
Assessment of serum IL-6 level
Samples of venous blood from the cubital vein will be taken from each patient. Collected blood samples will be transferred into a test tube pre-fabricated with an anticoagulant. The blood samples will remain in the test tubes for about 30 minutes and will then be distributed to a biochemical laboratory, where they will be centrifuged at 6,000 rpm for 10 minutes. The serum will be separated from the test tube and transferred to an Eppendorf tube. All serum samples will be stored at -80°C until complete analysis and measurement of IL-6 levels. The IL-6 level in the serum will then be determined. Additionally, fasting blood sugar levels will be measured to assess the stabilization of the condition.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Nov 2024 (estimated)
- Primary completion26 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Foot UlcerStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mahmoud Abd Allah Abd Alsadek, Cairo University
- Investigators
- Amal Mohamed Abd El-baky, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703762
- Sponsor's protocol ID
- P.T.REC/012/005252
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06703762
- Acronym / sponsor ID
- P.T.REC/012/005252
- Conditions
- Neuropathic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (estimated)
- Primary completion
- 26 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 25 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 aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer.
Detailed description
Wound healing is a complex, interactive, and integrative event, involving cellular and chemotactic activity with release of chemical mediators associated with vascular responses and cell proliferation. It consists in a sequence of events leading to the closure of dermal injuries. The repair follows steps of inflammation, re-epithelization, wound contraction, and matrix remodeling. The healing process can be influenced by various local and systemic factors.
The ulcer treatment in the diabetic foot requires a multidisciplinary approach, including revascularization and surgical procedures, as well as the infection treatment, physiotherapeutic rehabilitation with electric phototherapeutic resources to control edema, pain, metabolic disorders, tissue malnutrition, co morbidities, precise treatment of the wound and biomechanics' decompression that will help in amputation prevention.
Biophotomodulation in the form of Low level laser (LLL) irradiation can promote cell migration and cell proliferation by stimulating mitochondrial activity and maintaining viability without causing damage to the wounded cells.
The usage of LLLT presents itself as being a new therapeutic proposal, seeking the cure of these injuries, the improvement on the quality of life of the affected individuals, as well as the reduction of the costs of the treatment in the health system, this study aims to identify the effects of low-level laser therapy on neuropathic foot ulcer healing and the effect of LLL on the hyperglycemic-induced inflammatory response in IL-6 and sought to identify which pathway it might achieve this effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| He-Ne low level laser (LLL) + Conventional traditional treatment | Experimental | Other: He-Ne low level laser (LLL), Other: Conventional traditional treatmentIt will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive He-Ne LLL for chronic neuropathic foot ulcer with pulsed wave form, visible ray, wave length of 632.8 nm, peak potency of 30 mW, (Laser -HTM). The application time will be 80 (4 J/cm2) seconds. The application will be 3 sessions /week for 4 weeks on the sole of the foot + Conventional traditional treatment. |
| Conventional traditional treatment | Active comparator | Other: Conventional traditional treatmentIt will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive conventional traditional treatment (regular sharp debridement of calluses surrounding the ulcer, use of walking or total-contact casts for off-loading and regular moist dressing patients will be instructed to use only sodium chloride (saline solution 0.9%), regarding the daily asepsis of the ulcer). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patient will be diagnosed with neuropathic foot ulcer.
- All patient diagnosed as type II Diabetes Mellitus.
- Wound size a 6-12 cm2.
- Diabetic ulcers will be in grade 2 and 3 (Partial thickness skin loss involving epidermis and or dermis (superficial, abrasion, blister, and / or full thickness skin loss damage ore necrosis of subcutaneous tissue may extend down to but not through underlying fascia.
Key exclusion criteria (10 listed)
- Presence of osteomyelitis.
- Patients associated with critical illness who needs intensive care.
- Patients who suffer from cellulitis.
- Patients who suffer from nerve injury.
- Pregnancy.
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 |
|---|---|---|
| He-Ne low level laser (LLL)Patients in the experimental group will receive treatment with LLLT. The ulcer bed will be irradiated locally with red light (660 nm). The ulcer size and its depth will be used as the basis to calculate the duration of exposure needed to deliver 3-10 J/cm² for 15 to 20 minutes. The application will take place in 3 sessions per week for 4 weeks. Each patient will be asked to lie in a supine position with the ulcer easily exposed to the laser beam, and they will be instructed to wear laser glasses and avoid looking directly at the beam until the end of the session. | Other | He-Ne low level laser (LLL) + Conventional traditional treatment |
| Conventional traditional treatmentAll patients in both the groups will receive the required, conventional treatments of diabetic wound care, including dressing, antibiotics, controlling diabetes, cholesterol, and blood pressure along with aggressive drug treatment and wound debridement when needed. | Other | Conventional traditional treatment, He-Ne low level laser (LLL) + Conventional traditional treatment |
Primary outcome
Measurement of Ulcer Length
Time frame: 4 weeks
The length of the ulcer can be precisely measured using the Imito Measure application. By utilizing a specialized marker for calibration, the app allows users to trace the ulcer's longest dimension. After capturing an image, the app calculates the length automatically, providing an accurate measurement.
Measurement of Ulcer Width
Time frame: 4 weeks
The width of the ulcer is measured in a similar manner using the Imito Measure app. Users trace the widest part of the wound, and the app, after calibration with the marker, determines the exact width from the captured photo.
Measurement of Ulcer Area
Time frame: 4 weeks
The area of the ulcer is calculated by encircling the entire wound boundary using the Imito Measure application. The app uses the calibration marker to ensure accuracy and then automatically computes the total wound area. The Imito Measure application has been scientifically validated as a reliable alternative to traditional wound measurement methods, such as wound rulers.
Measurement of volume of the ulcer
Time frame: 4 weeks
It can be measured by using Syringe method by injecting saline into the wound until it overflows from the wound and measure the amount of saline.
Assessment of serum IL-6 level
Time frame: 4 weeks
Samples of venous blood from the cubital vein will be taken from each patient. Collected blood samples will be transferred into a test tube pre-fabricated with an anticoagulant. The blood samples will remain in the test tubes for about 30 minutes and will then be distributed to a biochemical laboratory, where they will be centrifuged at 6,000 rpm for 10 minutes. The serum will be separated from the test tube and transferred to an Eppendorf tube. All serum samples will be stored at -80°C until complete analysis and measurement of IL-6 levels. The IL-6 level in the serum will then be determined. Additionally, fasting blood sugar levels will be measured to assess the stabilization of the condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Hussein Gamal Hussein Mogahed, PhD contact
Amal Mohamed Abd El-baky, PhD study chair
Professor, Cairo 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 He-Ne low level laser (LLL) and Conventional traditional treatment in people with Neuropathic Foot Ulcer, 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc (01006400237, fatmaabdalsadek36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Ulcer Length (time frame: 4 weeks). The study lists 5 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 25 Nov 2024.