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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Ulcer
• Intervention / Treatment: Device: extra corporeal shock wave therapy (ESWT ); Device: Low Level Laser Therapy; Other: conservative treatments

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud awad elkholy, Lecturer of Physical Therapy; Phone Number: 01125746573; Email: elkholym774@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; study group (A) include 15 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	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
Active Comparator: Group B; study group (B) include 15 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	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.
Active Comparator: Group C; control group (C) include 15 old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment	Other: conservative treatments; ( compression pandaging, lifestyle changes, physical activities)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ulcer size	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. .	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire	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	4 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Publications and helpful links

General Publications

• Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.
• Cooper B, Bachoo P. Extracorporeal shock wave therapy for the healing and management of venous leg ulcers. Cochrane Database Syst Rev. 2018 Jun 11;6(6):CD011842. doi: 10.1002/14651858.CD011842.pub2.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: shock wave , low level laser
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Ulcer; Varicose Ulcer
• Other Study ID Numbers: FMBSUREC/02012024/AHMED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: university ethics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No