Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

NCT ID: NCT06756386

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-01

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

Conditions

Venous Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

extra corporeal shock wave therapy (ESWT )

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

conservative treatments

Intervention Type: OTHER

( compression pandaging, lifestyle changes, physical activities)

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

conservative treatments

( compression pandaging, lifestyle changes, physical activities)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Awad Ramadan Elkholy

Lecturer of Physical Therapy for Integumentary System and burn disorders, Faculty of Physical Therapy ,Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mahmoud awad elkholy, Lecturer of Physical Therapy

Role: CONTACT

elkholym774@gmail.com

01125746573

References

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.

Reference Type: BACKGROUND

PMID: 30001202 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29889978 (View on PubMed)

Other Identifiers

FMBSUREC/02012024/AHMED

Identifier Type: -

Identifier Source: org_study_id