Clinical trial NCT06756386: Shock Wave Versus Low Level Laser on Chronic Venous Ulcer
Official title: Effect of Extra Corporeal Shock Wave Versus Low Level Laser on Chronic Venous Ulcer Healing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Ulcer
Keywords: shock wave , low level laser
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: ulcer size
timeFrame: 4 weeks
Secondary outcomes:
measure: Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.