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

NCT ID: NCT05410613

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2022-06-20

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 .

Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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combined electromagnetic field and a plantar resistance

Group Type EXPERIMENTAL

electromagnetic field and a plantar resistance exercise

Intervention Type COMBINATION_PRODUCT

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).

electromagnetic field

Group Type EXPERIMENTAL

Pulsed electromagnetic field

Intervention Type DEVICE

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

conservative treatment for the ulcer

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

standard general advice according to hospital protocol

Interventions

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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).

Intervention Type COMBINATION_PRODUCT

Pulsed electromagnetic field

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

Intervention Type DEVICE

usual care

standard general advice according to hospital protocol

Intervention Type OTHER

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mona Mohamed Taha

OTHER

Sponsor Role lead

Responsible Party

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Mona Mohamed Taha

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ASMAA FAWZY EL-SAYED, lecturer

Role: PRINCIPAL_INVESTIGATOR

Surgical department-Mansoura Health Insurance Hospital

Locations

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Surgical department-Mansoura Health Insurance Hospital

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ASMAA FAWZY EL-SAYED, lecturer

Role: CONTACT

+201111351578

Facility Contacts

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asmaa

Role: primary

Other Identifiers

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P.T REC/012/003629

Identifier Type: -

Identifier Source: org_study_id

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