Venous Leg UlcerNCT04689620
Helium Neon Laser Versus Gallium Arsenide Laser
A study testing laser in people with Venous Leg Ulcer, run by Mahmoud Awad Ramadan Elkholy.
Trial summary
There will be different effects for different laser wavelengths in treatment of venous ulcer. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2020to Feb 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients approximately the same age (50-60).
- All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
- All patients with conscious.
Who cannot join
- All patients had no diabetes or blood problems.
- any immunity disorder affect wound heaing.
About this study
Official title: Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers
There will be different effects for different laser wavelengths in treatment of venous ulcer.
Read the detailed description
The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.
Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.
So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.
- Conditions
- Venous Leg Ulcer
- Being tested
- laser
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laserDevice
treating the venous ulcer with laser
| Study group | Role | What they receive |
|---|---|---|
| HELIUM NEON LASER plus regular ulcer care | Experimental | laser scanning the wound with 9.6 jole/cm2 then regular dressing Receives: Device: laser |
| GALLIUM ARSENIDE plus regular ulcer care | Experimental | laser scanning the wound with 9.6 jole/cm2 then regular dressing Receives: Device: laser |
| regular ulcer care | Active comparator | dressing for the ulcer Receives: Device: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound surface area
measuring the ulcer surface area by smart phone application
Measured: two months
number of bacteria in wound
measuring number of bacteria by colony count
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start26 Dec 2020 (estimated)
- Primary completion28 Dec 2020 (estimated)
- Study completionFeb 2021 (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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Awad Ramadan Elkholy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Awad Ramadan Elkholy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689620
- Sponsor's protocol ID
- Beni Suef University
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: statistical analysis plan
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers
- ClinicalTrials.gov ID
- NCT04689620
- Acronym / sponsor ID
- Beni Suef University
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahmoud Awad Ramadan ElkholyUniversity, hospital or other
- Study start
- 26 Dec 2020 (estimated)
- Primary completion
- 28 Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 30 Dec 2020 (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.
There will be different effects for different laser wavelengths in treatment of venous ulcer.
Detailed description
The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.
Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.
So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HELIUM NEON LASER plus regular ulcer care | Experimental | Device: laserlaser scanning the wound with 9.6 jole/cm2 then regular dressing |
| GALLIUM ARSENIDE plus regular ulcer care | Experimental | Device: laserlaser scanning the wound with 9.6 jole/cm2 then regular dressing |
| regular ulcer care | Active comparator | Device: laserdressing for the ulcer |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients approximately the same age (50-60).
- All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
- All patients with conscious.
Key exclusion criteria (2 listed)
- All patients had no diabetes or blood problems.
- any immunity disorder affect wound heaing.
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 |
|---|---|---|
| lasertreating the venous ulcer with laser | Device | GALLIUM ARSENIDE plus regular ulcer care, HELIUM NEON LASER plus regular ulcer care, regular ulcer care |
Primary outcome
wound surface area
Time frame: two months
measuring the ulcer surface area by smart phone application
number of bacteria in wound
Time frame: two months
measuring number of bacteria by colony count
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: Undecided. statistical analysis plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laser in people with Venous Leg Ulcer, run by Mahmoud Awad Ramadan Elkholy.
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 3 inclusion and 2 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
wound surface area (time frame: two months). 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 30 Dec 2020.