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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Combination product: electromagnetic field and a plantar resistance exercise; Device: Pulsed electromagnetic field; Other: usual care

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ASMAA FAWZY EL-SAYED, lecturer; Phone Number: +201111351578; Email: Zayedsameh40@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Surgical department-Mansoura Health Insurance Hospital
    • Contact: asmaa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined electromagnetic field and a plantar resistance	Combination product: electromagnetic field and a plantar resistance exercise; 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).
Experimental: electromagnetic field	Device: Pulsed electromagnetic field; Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz
Active Comparator: conservative treatment for the ulcer	Other: usual care; standard general advice according to hospital protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mona Mohamed Taha
• Investigators: Principal Investigator: ASMAA FAWZY EL-SAYED, lecturer, Surgical department-Mansoura Health Insurance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Anticipated): June 15, 2022
• Study Completion (Anticipated): June 20, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: P.T REC/012/003629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No