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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410613
• Other study ID #: P.T REC/012/003629
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: ASMAA FAWZY EL-SAYED, lecturer
• Phone: +201111351578
• Email: Zayedsameh40[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 20, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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).

Device:
• Pulsed electromagnetic field
Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz

Other:
• usual care
standard general advice according to hospital protocol

Locations

Country	Name	City	State
Egypt	Surgical department-Mansoura Health Insurance Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mona Mohamed Taha

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Pressure Ulcer Scale for Healing (PUSH)	Categorize the ulcer with respect to surface area, exudate, and type of wound tissue	two months