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

Sponsor

Mona Mohamed Taha (Other)

Overall Status

Recruiting

CT.gov ID

NCT05410613

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Venous Leg Ulcer	Combination Product: electromagnetic field and a plantar resistance exercise Device: Pulsed electromagnetic field Other: usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ulcer surface area [two months]
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.
Ulcer volume measurement [two months]
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
Pressure Ulcer Scale for Healing (PUSH) [two months]
Categorize the ulcer with respect to surface area, exudate, and type of wound tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical department-Mansoura Health Insurance Hospital	Mansoura		Egypt

Sponsors and Collaborators

Mona Mohamed Taha

Investigators

Principal Investigator: ASMAA FAWZY EL-SAYED, lecturer, Surgical department-Mansoura Health Insurance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mona Mohamed Taha, associate professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05410613

Other Study ID Numbers:

P.T REC/012/003629

First Posted:

Jun 8, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Varicose Ulcer

Leg Ulcer

Ulcer

Study Results

No Results Posted as of Jun 8, 2022