Back to resultsCombined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
Primary Purpose
Venous Leg Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electromagnetic field and a plantar resistance exercise
Pulsed electromagnetic field
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
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.
Sites / Locations
- Surgical department-Mansoura Health Insurance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
combined electromagnetic field and a plantar resistance
electromagnetic field
conservative treatment for the ulcer
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Pressure Ulcer Scale for Healing (PUSH)
Categorize the ulcer with respect to surface area, exudate, and type of wound tissue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05410613
Brief Title
Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
Official Title
Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mona Mohamed Taha
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
combined electromagnetic field and a plantar resistance
Arm Type
Experimental
Arm Title
electromagnetic field
Arm Type
Experimental
Arm Title
conservative treatment for the ulcer
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
electromagnetic field and a plantar resistance exercise
Intervention Description
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
Device
Intervention Name(s)
Pulsed electromagnetic field
Intervention Description
Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
standard general advice according to hospital protocol
Primary Outcome Measure Information:
Title
Ulcer surface area
Description
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
Title
Ulcer volume measurement
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH)
Description
Categorize the ulcer with respect to surface area, exudate, and type of wound tissue
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ASMAA FAWZY EL-SAYED, lecturer
Phone
+201111351578
Email
Zayedsameh40@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ASMAA FAWZY EL-SAYED, lecturer
Organizational Affiliation
Surgical department-Mansoura Health Insurance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical department-Mansoura Health Insurance Hospital
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
asmaa
12. IPD Sharing Statement
Learn more about this trial
Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
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