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NCT Number: NCT06756386

Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

To find out the difference in the effect of shock wave therapy and low level laser therapy on venous ulcer patient As regards the following outcomes;

1. medical state of patient no ( diabetes, hypertension,obesity,cancer , rheumatoid) 2. The degree of ulcer 3. recurrence of ulcer 4. The degree of pain and disabilities 5. inflammatory marker

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Key information

Conditions

Venous Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

45 venous ulcer patient of both sexes will be recruited in this study from cardiovascular units in nasser institute hospital , their age ranged from 45 to 60 years old and randomly divided into 3 equal groups

  • study group (A) include old age patients with venous ulcer will receive extra corporeal shock wave therapy along with conservative treatment (compression therapy (pressure garment),lifestyle changes, physical activity) plus medical treatment
  • study group (B) include old age patient with chronic venous ulcer will receive low level laser therapy along with conservative treatment (compression therapy (pressure garment), lifestyle changes,physical activity) Plus medical treatment
  • control group (C) include old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment The study will be conducted when the patient stable medically and will be conducted until complete healing of ulcer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All old age patients will be
  • Ranging from 45-60 years old
  • With BMI from (25-30)
  • Chronic venous ulcer grade 2 or 3
  • Ulcers non infected with superficial blood insufficiency
  • open ulcers.

Exclusion criteria

  • -Diabetes
  • hypertension
  • rheumatoid arthritis
  • Obesity
  • Musculoskeletal disorders
  • Dementia
  • cerbrovascular stroke
  • Deep venous thrombosis
  • deep venous ulcer
  • venous ulcer grade 4
  • smokers

Treatment and study plan

extra corporeal shock wave therapy (ESWT )

Device

Using wound area measurements and histological/immunohistochemical analysis of wound biopsies, we show ESWT enhanced healing of chronic ulcers associated with improved wound angiogenesis ), significantly decreased-positive macrophages per biopsy area and generally increased macrophage activity ,this activity prevent bacterial infection which delay healing

Low Level Laser Therapy

Device

Low-level laser therapy (LLLT) has been used as an adjuvant to conventional therapy with promising results,improve healing by delivering nutrient substances , especially in patients with acute and bloody ulcers.

Positive effects include acceleration of tissue repair, increased formation of granulation tissue, wound contraction, inflammation modulation, and pain reduction The biochemical effects of LLLT are associated with the release of preformed substances (histamine, serotonin, and bradykinin), which stimulate the production of ATP and inhibit the production of prostaglandins.

conservative treatments

Other

( compression pandaging, lifestyle changes, physical activities)

Primary outcomes

  1. ulcer size

    Time frame: 4 weeks

    Smart phone application imito wound application was found to be reliable for three-dimensional analysis such as depths and volumes, its results were less suited for immediate application to clinical environments. .

Secondary outcomes

  1. Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire

    Time frame: 4 weeks

    Veines questionnaire is a disease-specific quality of life instrument for chronic venous disorders of the leg .the responeses are rated on 2-point to 7- point response scales of intensity ,frequency, or agreement.These summary scores are transformed to T scores (mean, 50; standard deviation, 10) for easy interpretation.

    Participants whose ulcers had healed showed greater mean increase in scores than did those yet to heal, though they continued to report leg problems. An intrinsic scoring method appeared superior to the original relative method.

    VEINES-QOL was suitable for use in the study of venous leg ulcers. The intrinsic scoring method should be adopted, to facilitate comparisons between studies

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud awad elkholy, Lecturer of Physical Therapy

CONTACT

[email protected]

01125746573

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Extra Corporeal Shock Wave Versus Low Level Laser on Chronic Venous Ulcer Healing

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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