Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

ConditionVenous Ulcer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-60

SponsorBeni-Suef University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All old age patients will be

Ranging from 45-60 years old

With BMI from (25-30)

Chronic venous ulcer grade 2 or 3

Disqualifiers

-Diabetes

hypertension

rheumatoid arthritis

Obesity

Trial design

Design model

Parallel

Treatments tested in this trial

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
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.
conservative treatments
Other intervention
( compression pandaging, lifestyle changes, physical activities)

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: group AActive comparator 1 intervention

Group B: Group BActive comparator 1 intervention

Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

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. .

Time frame

4 weeks

Secondary outcomes

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

Time frame

4 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: