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Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06756386
Enrollment
45
Registered
2025-01-03
Start date
2025-01-01
Completion date
2025-07-01
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcer

Keywords

shock wave , low level laser

Brief summary

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

Detailed description

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 1. 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 2. 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 3. 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

Interventions

DEVICEextra corporeal shock wave therapy (ESWT )

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

DEVICELow Level Laser Therapy

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.

( compression pandaging, lifestyle changes, physical activities)

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

1. 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 2. 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 3. control group (C) include old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ulcer size4 weeksSmart 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

MeasureTime frameDescription
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire4 weeksVeines 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

Contacts

Primary ContactMahmoud awad elkholy, Lecturer of Physical Therapy
elkholym774@gmail.com01125746573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026