NCT06084754

Brief Summary

This study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

September 19, 2023

Last Update Submit

November 26, 2023

Conditions

Osteomyelitis

Keywords

OsteomyelitisPulsed Electromagnetic Field

Outcome Measures

Primary Outcomes (1)

  • Changing of osteomyelitis signs

    through CT scan

    pre treatment and post two months of treatment

Study Arms (2)

Group A (Study group)

EXPERIMENTAL

pulsed electromagnetic field and medical treatment ( vancomycin IV injection 1gm divided 250mg every 6hours )

Device: pulsed electromagnetic fieldDrug: Antibiotics

Group B(control group)

ACTIVE COMPARATOR

medical treatment only (vancomycin IV injection 1gm divided 250mg every 6hours )

Drug: Antibiotics

Interventions

pulsed electromagnetic fieldDEVICE

pulsed electromagnetic field will be over the site of osteomyelitis where patient in supine lying position. the treatment parameters will be set as10 HZ frequency , 20 gauss amplitude, duration about 120 minutes.

Also known as: CRYOMAG PROFESSIONAL.LEVEL,s.r.l
Group A (Study group)
AntibioticsDRUG

Vancomycin IV injection 1gm divided 250mg every 6hours

Group A (Study group)Group B(control group)

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients suffering from localized osteomyelitis in one or both lower limbs
  • All patients will be assessed by a physician before starting the study procedures.

You may not qualify if:

  • Patients with immune disorders .
  • Patients who suffer from any systemic diseases that may interfere with the objectives of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Osteomyelitis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Nessrien A. AbdelRashid, Ass.professor

    physical therapy, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Norhan M. Eltayeb, MSc candidate

CONTACT

012880539571400534@st.pt.cu.edu.eg

Nessrien A. AbdelRashid, Ass. professor

CONTACT

01143872680nessrien.afify@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 16, 2023

Study Start

November 27, 2023

Primary Completion

December 30, 2023

Study Completion

February 1, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

EG(1)