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Not yet recruiting NCT07557524

Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers

No phase Interventional Neuropathic Ulcers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser therapy, Negative pressure therapy is applied to the negative pressure group.
Who it may be relevant to
Registry conditions: Neuropathic Ulcers. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

PULSED HIGH INTENSITY LASER VERSUS NEGATIVE PRESSURE THERAPY ON NEUROPATHIC ULCERS

Overview

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

Interventions

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

Primary outcome measures

  • wound surface area [Time frame: one month]
Secondary outcome measures (1)
  • qulity of life [Time frame: one month and three months]

Eligibility criteria

Inclusion criteria

\-

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • ELshiek Zayed spicilized hospital — Giza

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

Identifiers

NCT: NCT07557524 · laser and vac in ulcers

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗