Helium Neon Laser Versus Gallium Arsenide Laser

Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers

There will be different effects for different laser wavelengths in treatment of venous ulcer.

Study Overview

• Status: Unknown
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: laser

Detailed Description

The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.

Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.

So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients approximately the same age (50-60).
• All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
• All patients with conscious.

Exclusion Criteria:

• All patients had no diabetes or blood problems.
• any immunity disorder affect wound heaing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HELIUM NEON LASER plus regular ulcer care; laser scanning the wound with 9.6 jole/cm2 then regular dressing	Device: laser; treating the venous ulcer with laser
Experimental: GALLIUM ARSENIDE plus regular ulcer care; laser scanning the wound with 9.6 jole/cm2 then regular dressing	Device: laser; treating the venous ulcer with laser
Active Comparator: regular ulcer care; dressing for the ulcer	Device: laser; treating the venous ulcer with laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound surface area	measuring the ulcer surface area by smart phone application	two months
number of bacteria in wound	measuring number of bacteria by colony count	two months

Collaborators and Investigators

• Sponsor: Mahmoud Awad Ramadan Elkholy

Study record dates

Study Major Dates

• Study Start (Anticipated): December 26, 2020
• Primary Completion (Anticipated): December 28, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: beni suef university (Other Identifier: beni suef university)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: statistical analysis plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes