Neuropathic UlcersVACNCT07557524
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
A study testing Laser therapy and Negative pressure therapy is applied to the negative pressure group in people with Neuropathic Ulcers, run by Cairo University at 1 site in Egypt.
Trial summary
the study comparess between laser therapy and vac to decide which on is superior Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Neuropathic Ulcers
- What is being tested?
- Laser therapy and Negative pressure therapy is applied to the negative pressure group
- 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
- 12 Nov 2026to 28 Feb 2027
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
- The subject selection will be according to the following criteria:
- Ages of patients will be ranged from 40 to 60 years.
- All patients have grade one, two and three neuropathic wound.
- Both male and female are included.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Patient with untreated osteomyelitis.
- Patients with active bleeding.
- Patients with prescription of anticoagulant.
- Patients with associated bone fractures.
- Patients with malignancy.
- Patients with diminished cognitive capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PULSED HIGH INTENSITY LASER VERSUS NEGATIVE PRESSURE THERAPY ON NEUROPATHIC ULCERS
the study comparess between laser therapy and vac to decide which on is superior
Read the detailed description
the vac will be used for 4 weeks the laser will be used for 3 session per weak for four weaks
- Conditions
- Neuropathic Ulcers
- Being tested
- Laser therapy, Negative pressure therapy is applied to the negative pressure group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyDevice
Pulsed high intensity laser therapy is applied to wound bed
Negative pressure therapy is applied to the negative pressure groupDevice
It will be applied to patients with chronic wound
| Study group | Role | What they receive |
|---|---|---|
| laser group | Active comparator | In this group of the study, will receive pulsed High intensity laser therapy (GaAs laser) in addition to traditional wound management for 3 sessions per week for four weeks at 980 nm laser irradiation at 15 W at 20hz laser emission potently stimulates defens in production in keratinocytes via ROS-mediated pathways. While these in vitro parameters highlight mechanistic efficacy, clinical translation for chronic wounds requires: Non-contact scanning techniques Receives: Device: Laser therapy |
| negative pressure wound therapy | Active comparator | In this group of the study, will receive negative pressure wound therapy in addition to traditional wound management for four weeks. Receives: Device: Negative pressure therapy is applied to the negative pressure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound surface area
imitoMeasure Mobil application: The ImitoMeasure app is a noncontact digital planimetry application that measures wound surface area and offers an advantage over other methods. The introduction of smartphones with high-definition cameras. These devices are not only portable and inexpensive, but they also provide the convenience of on-the-spot assessments.
Measured: one month
Secondary outcomes (1)
qulity of life
Wound quality of life questionnaire The Wound-QoL questionnaire has been tested in a previous study, indicating that it is a reliable and valid tool for assessing HRQoL in chronic wounds. It contains 17 items, each with a 5-point Likert scale (0 = not at all, 4 = very much).
Measured: one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start12 Nov 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic UlcersStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna El-Rafaie, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557524
- Sponsor's protocol ID
- laser and vac in ulcers
- Acronym
- VAC
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tang Y, Liu L, Jie R, Tang Y, Zhao X, Xu M, Chen M. Negative pressure wound therapy promotes wound healing of diabetic foot ulcers by up-regulating PRDX2 in wound margin tissue. Sci Rep. 2023 Sep 27;13(1):16192. doi: 10.1038/s41598-023-42634-9.
PubMed 37758743Leclere FM, Puechguiral IR, Rotteleur G, Thomas P, Mordon SR. A prospective randomized study of 980 nm diode laser-assisted venous ulcer healing on 34 patients. Wound Repair Regen. 2010 Nov-Dec;18(6):580-5. doi: 10.1111/j.1524-475X.2010.00637.x. Epub 2010 Oct 19.
PubMed 20958856
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSED HIGH INTENSITY LASER VERSUS NEGATIVE PRESSURE THERAPY ON NEUROPATHIC ULCERS
- ClinicalTrials.gov ID
- NCT07557524
- Acronym / sponsor ID
- VAC / laser and vac in ulcers
- Conditions
- Neuropathic Ulcers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Apr 2026 (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 comparess between laser therapy and vac to decide which on is superior
Detailed description
the vac will be used for 4 weeks the laser will be used for 3 session per weak for four weaks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser group | Active comparator | Device: Laser therapyIn this group of the study, will receive pulsed High intensity laser therapy (GaAs laser) in addition to traditional wound management for 3 sessions per week for four weeks at 980 nm laser irradiation at 15 W at 20hz laser emission potently stimulates defens in production in keratinocytes via ROS-mediated pathways. While these in vitro parameters highlight mechanistic efficacy, clinical translation for chronic wounds requires: Non-contact scanning techniques |
| negative pressure wound therapy | Active comparator | Device: Negative pressure therapy is applied to the negative pressure groupIn this group of the study, will receive negative pressure wound therapy in addition to traditional wound management for four weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -
- Ages of patients will be ranged from 40 to 60 years.
- All patients have grade one, two and three neuropathic wound.
- Both male and female are included.
Key exclusion criteria (7 listed)
- Patient with untreated osteomyelitis.
- Patients with active bleeding.
- Patients with prescription of anticoagulant.
- Patients with associated bone fractures.
- Patients with malignancy.
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 |
|---|---|---|
| Laser therapyPulsed high intensity laser therapy is applied to wound bed | Device | laser group |
| Negative pressure therapy is applied to the negative pressure groupIt will be applied to patients with chronic wound | Device | negative pressure wound therapy |
Primary outcome
wound surface area
Time frame: one month
imitoMeasure Mobil application: The ImitoMeasure app is a noncontact digital planimetry application that measures wound surface area and offers an advantage over other methods. The introduction of smartphones with high-definition cameras. These devices are not only portable and inexpensive, but they also provide the convenience of on-the-spot assessments.
1 secondary outcome
qulity of life
Time frame: one month and three months
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 5 Nov 2026.
- Background: PubMed 37758743Tang Y, Liu L, Jie R, Tang Y, Zhao X, Xu M, Chen M. Negative pressure wound therapy promotes wound healing of diabetic foot ulcers by up-regulating PRDX2 in wound margin tissue. Sci Rep. 2023 Sep 27;13(1):16192. doi: 10.1038/s41598-023-42634-9.
- Background: PubMed 20958856Leclere FM, Puechguiral IR, Rotteleur G, Thomas P, Mordon SR. A prospective randomized study of 980 nm diode laser-assisted venous ulcer healing on 34 patients. Wound Repair Regen. 2010 Nov-Dec;18(6):580-5. doi: 10.1111/j.1524-475X.2010.00637.x. Epub 2010 Oct 19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy and Negative pressure therapy is applied to the negative pressure group in people with Neuropathic Ulcers, 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 5 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
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: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557524, which also lists 2 linked publications.
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 2026.