Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

NCT06756386 | Not Yet Recruiting

• 1 other identifier: FMBSUREC/02012024/AHMED
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Venous Ulcer

Keywords

shock wave , low level laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  4 weeks

Study Arms (3)

group A

ACTIVE COMPARATOR

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 )

Group B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Interventions

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

group A

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.

Group B

conservative treatments OTHER

( compression pandaging, lifestyle changes, physical activities)

Group C

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Related Publications (2)

• 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.

  PMID: 30001202 BACKGROUND

• 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.

  PMID: 29889978 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Low-Level Light Therapy; Conservative Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Mahmoud awad elkholy, Lecturer of Physical Therapy

CONTACT

01125746573; elkholym774@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Integumentary System and burn disorders, Faculty of Physical Therapy ,Beni-Suef University

Model Details: 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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12