NCT06756386

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
DEVICE	extra 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
DEVICE	Low 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.
OTHER	conservative treatments	( compression pandaging, lifestyle changes, physical activities)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2025-01-03
• Last updated: 2025-01-03