Venous Leg UlcerNCT05410613
Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
A study testing electromagnetic field and a plantar resistance exercise and Pulsed electromagnetic field in people with Venous Leg Ulcer, run by Mona Mohamed Taha at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- electromagnetic field and a plantar resistance exercise and Pulsed electromagnetic field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with venous leg ulcer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Surgical department-Mansoura Health Insurance Hospital
Al Mansurah
asmaa
About this study
Official title: Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer
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 .
- Conditions
- Venous Leg Ulcer
- Being tested
- electromagnetic field and a plantar resistance exercise, Pulsed electromagnetic field, usual care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnetic field and a plantar resistance exerciseCombination 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).
Pulsed electromagnetic fieldDevice
Pulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz
usual careOther
standard general advice according to hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| combined electromagnetic field and a plantar resistance | Experimental | Not described Receives: Combination Product: electromagnetic field and a plantar resistance exercise |
| electromagnetic field | Experimental | Not described Receives: Device: Pulsed electromagnetic field |
| conservative treatment for the ulcer | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: two months
Pressure Ulcer Scale for Healing (PUSH)
Categorize the ulcer with respect to surface area, exudate, and type of wound tissue
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start20 Jan 2022
- Primary completion15 Jun 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona Mohamed Taha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mona Mohamed Taha, Cairo University
- Investigators
- ASMAA FAWZY EL-SAYED, lecturer, Principal investigator, Surgical department-Mansoura Health Insurance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410613
- Sponsor's protocol ID
- P.T REC/012/003629
- Status last verified
- Jun 2022
- First submitted
- 14 Mar 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer
- ClinicalTrials.gov ID
- NCT05410613
- Acronym / sponsor ID
- P.T REC/012/003629
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mona Mohamed TahaUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined electromagnetic field and a plantar resistance | Experimental | Combination Product: electromagnetic field and a plantar resistance exercise |
| electromagnetic field | Experimental | Device: Pulsed electromagnetic field |
| conservative treatment for the ulcer | Active comparator | Other: usual care |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with venous leg ulcer
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromagnetic field and a plantar resistance exercisePulsed 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). | Combination product | combined electromagnetic field and a plantar resistance |
| Pulsed electromagnetic fieldPulsed electromagnetic field therapy applied with intensity equal to 3mt and frequency of magnetic field impulses equal to 4 Hz | Device | electromagnetic field |
| usual carestandard general advice according to hospital protocol | Other | conservative treatment for the ulcer |
Primary outcome
Ulcer surface area
Time frame: 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
Time frame: 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)
Time frame: two months
Categorize the ulcer with respect to surface area, exudate, and type of wound tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASMAA FAWZY EL-SAYED, lecturer principal investigator
Surgical department-Mansoura Health Insurance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnetic field and a plantar resistance exercise and Pulsed electromagnetic field in people with Venous Leg Ulcer, run by Mona Mohamed Taha at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASMAA FAWZY EL-SAYED, lecturer (+201111351578, Zayedsameh40@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer surface area (time frame: two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.