Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer

Study Overview
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Brief Summary
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The purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg ulcer .

Official Title
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Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Combination Product: electromagnetic field and a plantar resistance exercise
* Device: Pulsed electromagnetic field
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with venous leg ulcer Exclusion Criteria: patients who have one or more of the following conditions: peripheral vascular disease (PVD), (ABPI<0.8). venous leg ulcers with cellulitis or infection symptoms, as well as venous leg ulcers with necrotic tissue or slough or had more than one ulcer. other types of ulcers, such as rheumatoid vasculitis, diabetic foot, and malignant ulceration; corticosteroids use ; patients with dementia or who were disoriented; undertaken another physical therapy modality for ulcer healing.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined electromagnetic field and a plantar resistance<br> | Combination Product: electromagnetic field and a plantar resistance exercise<br>* Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz. a plantar resistance exercise therapy by the StepIt rocker pedal, the overall exercise program will be to exercise on the pedal with the index leg for 1 min - then rest it for 1min - and to repeat this 10 times (20 minutes). This regime will be done twice daily (e.g .morning and evening).<br>|
| Experimental: electromagnetic field<br> | Device: Pulsed electromagnetic field<br>* Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz<br>|
| Active Comparator: conservative treatment for the ulcer<br> | Other: usual care<br>* standard general advice according to hospital protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer surface area | Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker. | two months | 
| Ulcer volume measurement | Ulcer volume : The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width. A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth. (Width x length x depth) would be calculated to have the volume of the ulcer | two months | 
| Pressure Ulcer Scale for Healing (PUSH) | Categorize the ulcer with respect to surface area, exudate, and type of wound tissue | two months |