NCT07557524

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 29, 2026

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Neuropathic Ulcers

Outcome Measures

Primary Outcomes (1)

  • 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.

    one month

Secondary Outcomes (1)

  • qulity of life

    one month and three months

Study Arms (2)

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

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.

Device: Negative pressure therapy is applied to the negative pressure group

Interventions

Laser therapyDEVICE

Pulsed high intensity laser therapy is applied to wound bed

laser group
Negative pressure therapy is applied to the negative pressure groupDEVICE

It will be applied to patients with chronic wound

negative pressure wound therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ELshiek Zayed spicilized hospital

Giza, Egypt

Location

Related Publications (2)

  • Tang, Y., Liu, L., Jie, R., Tang, Y., Zhao, X., Xu, M., & Chen, M. (2023). Negative pressure wound therapy promotes wound healing of diabetic foot ulcers by up-regulating PRDX2 in wound margin tissue. Scientific reports, 13(1), 16192. https://doi.org/10.1038/s41598-023-42634-9

    BACKGROUND

  • 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: 20958856BACKGROUND

Related Links

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy practitioner

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 29, 2026

Record last verified: 2025-09

Locations

EG(1)