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Helium Neon Laser Versus Gallium Arsenide Laser

NCT ID: NCT04689620

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-26

Study Completion Date

2021-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HELIUM NEON LASER plus regular ulcer care

laser scanning the wound with 9.6 jole/cm2 then regular dressing

Group Type EXPERIMENTAL

laser

Intervention Type DEVICE

treating the venous ulcer with laser

GALLIUM ARSENIDE plus regular ulcer care

laser scanning the wound with 9.6 jole/cm2 then regular dressing

Group Type EXPERIMENTAL

laser

Intervention Type DEVICE

treating the venous ulcer with laser

regular ulcer care

dressing for the ulcer

Group Type ACTIVE_COMPARATOR

laser

Intervention Type DEVICE

treating the venous ulcer with laser

Interventions

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laser

treating the venous ulcer with laser

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Awad Ramadan Elkholy

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Awad Ramadan Elkholy

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Beni Suef University

Identifier Type: -

Identifier Source: org_study_id