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
1 other identifier
interventional
60
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedFirst Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedJune 8, 2022
June 1, 2022
5 months
March 14, 2022
June 5, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
combined electromagnetic field and a plantar resistance
EXPERIMENTALelectromagnetic field
EXPERIMENTALconservative treatment for the ulcer
ACTIVE COMPARATORInterventions
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).
Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz
standard general advice according to hospital protocol
Eligibility Criteria
You may qualify if:
- patients with venous leg ulcer
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Surgical department-Mansoura Health Insurance Hospital
Al Mansurah, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ASMAA FAWZY EL-SAYED, lecturer
Surgical department-Mansoura Health Insurance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 14, 2022
First Posted
June 8, 2022
Study Start
January 20, 2022
Primary Completion
June 15, 2022
Study Completion
June 20, 2022
Last Updated
June 8, 2022
Record last verified: 2022-06