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Status unknownNCT05410613Updated Jun 8, 2022

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

An interventional study of electromagnetic field and a plantar resistance exercise and Pulsed electromagnetic field in Venous Leg Ulcer, sponsored by Mona Mohamed Taha. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-06-08.

Sponsored by Mona Mohamed Taha · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Venous Leg Ulcer
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

This is the only study on the registry with Mona Mohamed Taha as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

patients with venous leg ulcer

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    combined electromagnetic field and a plantar resistance

    Combination Product: electromagnetic field and a plantar resistance exercise

  • Experimental
    electromagnetic field

    Device: Pulsed electromagnetic field

  • Active comparator
    conservative treatment for the ulcer

    Other: usual care

Interventions

  • Combination productelectromagnetic 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).

  • DevicePulsed electromagnetic field

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

  • Otherusual care

    standard general advice according to hospital protocol

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: two months

  2. 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

    Time frame: two months

  3. Pressure Ulcer Scale for Healing (PUSH)

    Categorize the ulcer with respect to surface area, exudate, and type of wound tissue

    Time frame: two months

07

Study locations

1 of 1 sites recruiting
  • Surgical department-Mansoura Health Insurance Hospital
    Mansoura, Egypt
    • asmaa · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05410613
Lead sponsor
Mona Mohamed Taha
Responsible party
Mona Mohamed Taha (associate professor, Cairo University) — Sponsor-investigator
First posted
Jun 8, 2022
Start date
Jan 20, 2022
Primary completion
Jun 15, 2022 (estimated)
Completion
Jun 20, 2022 (estimated)
Last update
Jun 8, 2022

Study contacts

ASMAA FAWZY EL-SAYED, lecturer
Contact
Zayedsameh40@yahoo.com
+201111351578
ASMAA FAWZY EL-SAYED, lecturer
principal investigator · Surgical department-Mansoura Health Insurance Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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