Charcot Foot UlcerNCT06527131
Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer
A study testing pulsed electromagnetic field therapy, Transcutanous electrical nerve stimulation and Vancomycin in people with Charcot Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial summary
thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months . Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Charcot Foot Ulcer
- What is being tested?
- pulsed electromagnetic field therapy, Transcutanous electrical nerve stimulation and Vancomycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2024to Nov 2024
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer
Who cannot join
- presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer: a Randomized Controlled Trial
thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .
control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment
- Conditions
- Charcot Foot Ulcer
- Being tested
- pulsed electromagnetic field therapy, Transcutanous electrical nerve stimulation, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic field therapyDevice
Also called PEMF
PEMF is regarded as an efficient physical therapy method that has been utilized clinically to treat a variety of orthopedic conditions, including delayed union and nonunion of fractures. According to studies, PEMF has been authorized for its biological effects, which include the mineralization of bone matrix, osteogenic differentiation of mesenchymal stem cells, and osteoblast proliferation
Transcutanous electrical nerve stimulationDevice
Also called TENS
Electrical stimulation consider a safe and cost-effective method for pain management. It has no side effects and few contraindication in addition to no drug interaction . According to studies ,electrical stimulation decreases pain through reducing central transmission of pain signals because of nociceptive inhibition at the presynaptic level in the dorsal horn.
VancomycinDrug
medical antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Group A (Study group) | Experimental | PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation Receives: Device: pulsed electromagnetic field therapy; Device: Transcutanous electrical nerve stimulation |
| Group B(control group) | Active comparator | who recieves standard wound care , electrical stimulation and medical treatment Receives: Device: Transcutanous electrical nerve stimulation; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of bone healing
asses rate of bone healing through plain x-ray after six weeks then after twelve weeks from initiation of treatment
Measured: Baseline and three months
Secondary outcomes (1)
ulcrer healing
asses wound surface area through wound surface area Tracing pre treatment ,after six weeks and after twelve weeks from initiation of treatment
Measured: baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot Foot UlcerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Mohamed Eltayeb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527131
- Sponsor's protocol ID
- P.T.REC/012/005154
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06527131
- Acronym / sponsor ID
- P.T.REC/012/005154
- Conditions
- Charcot Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Jul 2024 (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.
thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .
control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Study group) | Experimental | Device: pulsed electromagnetic field therapy, Device: Transcutanous electrical nerve stimulationPEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation |
| Group B(control group) | Active comparator | Device: Transcutanous electrical nerve stimulation, Drug: Vancomycinwho recieves standard wound care , electrical stimulation and medical treatment |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer
Key exclusion criteria (1 listed)
- presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
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 |
|---|---|---|
| pulsed electromagnetic field therapyAlso: PEMFPEMF is regarded as an efficient physical therapy method that has been utilized clinically to treat a variety of orthopedic conditions, including delayed union and nonunion of fractures. According to studies, PEMF has been authorized for its biological effects, which include the mineralization of bone matrix, osteogenic differentiation of mesenchymal stem cells, and osteoblast proliferation | Device | Group A (Study group) |
| Transcutanous electrical nerve stimulationAlso: TENSElectrical stimulation consider a safe and cost-effective method for pain management. It has no side effects and few contraindication in addition to no drug interaction . According to studies ,electrical stimulation decreases pain through reducing central transmission of pain signals because of nociceptive inhibition at the presynaptic level in the dorsal horn. | Device | Group A (Study group), Group B(control group) |
| Vancomycinmedical antibiotics | Drug | Group B(control group) |
Primary outcome
rate of bone healing
Time frame: Baseline and three months
asses rate of bone healing through plain x-ray after six weeks then after twelve weeks from initiation of treatment
1 secondary outcome
ulcrer healing
Time frame: baseline and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed electromagnetic field therapy, Transcutanous electrical nerve stimulation and Vancomycin in people with Charcot Foot Ulcer, 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?
The sponsor lists 1 inclusion and 1 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 30 Jul 2024. 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 Norhan Eltayeb, MSc candidate (01288053957, 1400534@st.pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of bone healing (time frame: Baseline and three months). 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 30 Jul 2024.