Venous Leg UlcerNCT06135246
Laser Therapy for Venous Leg Ulcers
A study testing High Intensity Laser Therapy in people with Venous Leg Ulcer and Varicose Ulcer, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Leg Ulcer, Varicose Ulcer, Stasis Ulcer
- What is being tested?
- High Intensity Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Nov 2023to 1 Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 years up to 65 years.
- Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux > 0.5 seconds).
- Ulcer size between 1 cm² and 20 cm² at screening.
- Ulcer duration of at least 4 weeks but not more than 12 months.
- Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
- Willing and able to provide informed consent and comply with study procedures.
Who cannot join
- Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
- Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
- Patients with a history of uncontrolled diabetes, defined as HbA1c level > 10%.
- Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
- Pregnant or breastfeeding women.
- Patients with a history of malignancy or photosensitive skin disorders.
- Prior history of skin grafting or flap surgery in the affected area within the past 3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.
- Conditions
- Venous Leg Ulcer, Varicose Ulcer, Stasis Ulcer
- Being tested
- High Intensity Laser Therapy, Standard Care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser TherapyDevice
Also called HILT
Participants will receive high-intensity laser therapy using an 810nm continuous wave diode laser (Multiwave locked System (MlS) provided by aSa). The laser applicator has a flat top hat beam profile with a spot size of 1cm2. The laser will be delivered in direct contact mode perpendicularly to the ulcer surface. Each 1cm2 area of the venous ulcer and a 1cm margin of periwound skin will be treated sequentially using a overlapping grid pattern to cover the entire ulcer area, with a 1 second exposure time per point. This results in a laser energy density of 4J/cm2 delivered to each point.
Standard CareOther
Participants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care group | Active comparator | Participants will receive standard compression bandaging and wound care alone without high-intensity laser therapy. Bandaging will be applied weekly and wound care will be performed as per institutional protocols. Receives: Other: Standard Care |
| High Intensity laser therapy + Standard care group | Experimental | Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care. Receives: Device: High Intensity Laser Therapy; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in ulcer area from baseline to end of treatment
Ulcer area will be measured by tracing the wound perimeter on acetate paper and entering into image analysis software to calculate area in cm2. Percent change in ulcer area will be calculated as (area at end of treatment - area at baseline) / area at baseline x 100.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization
Secondary outcomes (4)
Rate of complete ulcer closure at end of treatment
Complete closure is defined as full re-epithelialization of the ulcer with no drainage. Assessed by clinical examination and tracing wound area as 0cm2. Reported as proportion of participants with complete closure.
Measured: Single time point at end of study at 12 weeks
Time to complete ulcer closure
Number of days from initial treatment until first point at which complete ulcer closure is achieved and maintained through end of treatment period.
Measured: From baseline (week 0) until complete closure, up to 12 weeks.
Changes in Quality of life
The Cardiff Wound Impact Schedule is a condition-specific quality of life questionnaire designed for patients with chronic wounds. It contains 15 questions assessing physical symptoms and daily living. Each item is rated on a 4-point Likert scale from 1 (never) to 4 (all the time). Total score ranges from 15 to 60, with higher scores indicating poorer quality of life.
Measured: Change in total score on the Cardiff Wound Impact Schedule will be assessed from baseline (week 0), 4 weeks, 8 weeks and 12 weeks after randomization
Incidence of treatment-related adverse events
Adverse events will be graded per CTCAE v4.0. Number of participants experiencing each severity grade of adverse event related to study treatment will be reported.
Measured: From initial treatment until 4 weeks after final treatment, up to 12 weeks total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Nov 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.D, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135246
- Sponsor's protocol ID
- VLU-HILT-2023
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06135246
- Acronym / sponsor ID
- VLU-HILT-2023
- Conditions
- Venous Leg Ulcer, Varicose Ulcer, Stasis Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care group | Active comparator | Other: Standard CareParticipants will receive standard compression bandaging and wound care alone without high-intensity laser therapy. Bandaging will be applied weekly and wound care will be performed as per institutional protocols. |
| High Intensity laser therapy + Standard care group | Experimental | Device: High Intensity Laser Therapy, Other: Standard CareParticipants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 years up to 65 years.
- Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux > 0.5 seconds).
- Ulcer size between 1 cm² and 20 cm² at screening.
- Ulcer duration of at least 4 weeks but not more than 12 months.
- Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
Key exclusion criteria (7 listed)
- Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
- Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
- Patients with a history of uncontrolled diabetes, defined as HbA1c level > 10%.
- Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| High Intensity Laser TherapyAlso: HILTParticipants will receive high-intensity laser therapy using an 810nm continuous wave diode laser (Multiwave locked System (MlS) provided by aSa). The laser applicator has a flat top hat beam profile with a spot size of 1cm2. The laser will be delivered in direct contact mode perpendicularly to the ulcer surface. Each 1cm2 area of the venous ulcer and a 1cm margin of periwound skin will be treated sequentially using a overlapping grid pattern to cover the entire ulcer area, with a 1 second exposure time per point. This results in a laser energy density of 4J/cm2 delivered to each point. | Device | High Intensity laser therapy + Standard care group |
| Standard CareParticipants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015). | Other | High Intensity laser therapy + Standard care group, Standard Care group |
Primary outcome
Percent change in ulcer area from baseline to end of treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization
Ulcer area will be measured by tracing the wound perimeter on acetate paper and entering into image analysis software to calculate area in cm2. Percent change in ulcer area will be calculated as (area at end of treatment - area at baseline) / area at baseline x 100.
4 secondary outcomes
Rate of complete ulcer closure at end of treatment
Time frame: Single time point at end of study at 12 weeks
Time to complete ulcer closure
Time frame: From baseline (week 0) until complete closure, up to 12 weeks.
Changes in Quality of life
Time frame: Change in total score on the Cardiff Wound Impact Schedule will be assessed from baseline (week 0), 4 weeks, 8 weeks and 12 weeks after randomization
Incidence of treatment-related adverse events
Time frame: From initial treatment until 4 weeks after final treatment, up to 12 weeks total.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Amal Fawzy, Ph.D study chair
Faculty of Physical Therapy, Ahram Canadian 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 High Intensity Laser Therapy in people with Venous Leg Ulcer and Varicose Ulcer, run by Ahram Canadian 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 7 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 18 Nov 2023. 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 Mohamed ElMeligie, Ph.D (01159880001, mmahm1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in ulcer area from baseline to end of treatment (time frame: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization). 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 18 Nov 2023.