Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

Beni-Suef University

Status: Not yet enrolling

Conditions: Venous Ulcer

Treatments: Device: extra corporeal shock wave therapy (ESWT ); Device: Low Level Laser Therapy; Other: conservative treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT06756386

FMBSUREC/02012024/AHMED

Details and patient eligibility

About

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

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

group A

Active Comparator group

Description:

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

Treatment:

Device: extra corporeal shock wave therapy (ESWT )

Group B

Active Comparator group

Description:

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

Treatment:

Device: Low Level Laser Therapy

Group C

Active Comparator group

Description:

control group (C) include 15 old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment

Treatment:

Other: conservative treatments