Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

Not Applicable

Not yet recruiting

• Conditions: Venous Ulcer

• Registration Number: NCT06756386
• Lead Sponsor: Beni-Suef University

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ulcer size	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 Outcome Measures

Name	Time	Method
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire	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