Burn WoundNCT05341427
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
A study testing electromagnetic device in people with Burn Wound, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Burn Wound
- What is being tested?
- electromagnetic device
- 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
- 1 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other inflammatory and/or infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients
Read the detailed description
It will be hypothesized that
- Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.
- TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves
- Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves
- Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.
Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area.
PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)
- Conditions
- Burn Wound
- Being tested
- electromagnetic device
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnetic deviceDevice
electromagnetic waves for burn wound
| Study group | Role | What they receive |
|---|---|---|
| burn wound receiving electromagnetic therapy | Experimental | There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units of Cairo university hospitals Receives: Device: electromagnetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing rate
tools for assessment of wound area changes before and after treatment
Measured: maximum of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 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 Burn WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mohamed nagy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341427
- Sponsor's protocol ID
- P.T.REC/012/003534
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
- ClinicalTrials.gov ID
- NCT05341427
- Acronym / sponsor ID
- P.T.REC/012/003534
- Conditions
- Burn Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 22 Apr 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 is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients
Detailed description
It will be hypothesized that
- Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.
- TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves
- Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves
- Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.
Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area.
PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| burn wound receiving electromagnetic therapy | Experimental | Device: electromagnetic deviceThere will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units of Cairo university hospitals |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 deviceelectromagnetic waves for burn wound | Device | burn wound receiving electromagnetic therapy |
Primary outcome
wound healing rate
Time frame: maximum of 6 weeks
tools for assessment of wound area changes before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 device in people with Burn Wound, run by Cairo University 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?
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 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing rate (time frame: maximum of 6 weeks). 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 3 Jun 2022.