Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers (VAC)

April 23, 2026 updated by: Yomna El-Rafaie, Cairo University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • ELshiek Zayed spicilized hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laser group
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
Device: Laser therapy
Pulsed high intensity laser therapy is applied to wound bed
Active Comparator: negative pressure wound therapy
In this group of the study, will receive negative pressure wound therapy in addition to traditional wound management for four weeks.
Device: Negative pressure therapy is applied to the negative pressure group
It will be applied to patients with chronic wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qulity of life
Time Frame: 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).
one month and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laser and vac in ulcers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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