Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers

NCT07557524 — Not applicable, Not yet recruiting, 70 participants, Cairo University

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PULSED HIGH INTENSITY LASER VERSUS NEGATIVE PRESSURE THERAPY ON NEUROPATHIC ULCERS

Registry	NCT07557524, acronym VAC
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	70 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Neuropathic Ulcers
Interventions	Laser therapy, Negative pressure therapy is applied to the negative pressure group (Device)
Dates	start 2026-04-30 (estimated), primary completion 2026-09-30 (estimated), completion 2026-09-30 (estimated), first posted 2026-04-29, last updated 2026-04-29
Locations	1 site in Egypt

-Summary

the study comparess between laser therapy and vac to decide which on is superior

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+Detailed description

the vac will be used for 4 weeks the laser will be used for 3 session per weak for four weaks

+Arms and interventions

Arm	Type	Interventions	Description
laser group	Active comparator	Device: Laser therapy	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
negative pressure wound therapy	Active comparator	Device: Negative pressure therapy is applied to the negative pressure group	In this group of the study, will receive negative pressure wound therapy in addition to traditional wound management for four weeks.

Laser therapy (Device): Pulsed high intensity laser therapy is applied to wound bed
Negative pressure therapy is applied to the negative pressure group (Device): It will be applied to patients with chronic wound

+Outcome measures

Primary outcomes

wound surface area [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.

Secondary outcomes

qulity of life [one month and three months]: 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).

+Eligibility

Sex: All, ages: 40 Years to 60 Years

Inclusion Criteria:

\-

The subject selection will be according to the following criteria:

1. Ages of patients will be ranged from 40 to 60 years.
2. All patients have grade one, two and three neuropathic wound.
3. Both male and female are included.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

1. Patient with untreated osteomyelitis.
2. Patients with active bleeding.
3. Patients with prescription of anticoagulant.
4. Patients with associated bone fractures.
5. Patients with malignancy.
6. Patients with diminished cognitive capacity.

+Locations (1)

Facility	City	Country	Status
ELshiek Zayed spicilized hospital	Giza	Egypt

+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. PMID 37758743
Leclere 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. PMID 20958856