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RecruitingNCT06527131Updated Jul 30, 2024

Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

An interventional study of pulsed electromagnetic field therapy and Transcutanous electrical nerve stimulation in Charcot Foot Ulcer, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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 .

control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment

02

Conditions studied

  • Charcot Foot Ulcer

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03

In context

Foot Ulcer

691 studies on the registry are indexed under Foot Ulcer; 96 are open to participants now.

This study's planned enrollment of 34 is below the median of 60 across 562 interventional studies indexed under Foot Ulcer.

Browse Foot Ulcer studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer

Exclusion criteria

Exclusion Criteria:

  • presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Group A (Study group)

    PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation

    Device: pulsed electromagnetic field therapy · Device: Transcutanous electrical nerve stimulation

  • Active comparator
    Group B(control group)

    who recieves standard wound care , electrical stimulation and medical treatment

    Device: Transcutanous electrical nerve stimulation · Drug: Vancomycin

Interventions

  • Devicepulsed electromagnetic field therapy

    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

    Also known as: PEMF

  • DeviceTranscutanous electrical nerve stimulation

    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.

    Also known as: TENS

  • DrugVancomycin

    medical antibiotics

06

What researchers measure

Primary outcomes

  1. rate of bone healing

    asses rate of bone healing through plain x-ray after six weeks then after twelve weeks from initiation of treatment

    Time frame: 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

    Time frame: baseline and three months

07

Study locations

1 of 1 sites recruiting
  • Physical Therapy Cairo University
    Giza, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06527131
Lead sponsor
Cairo University
Responsible party
Norhan Mohamed Eltayeb (Bachelor's degree, MSc candidate, Cairo University) — Principal investigator
First posted
Jul 30, 2024
Start date
Jul 2024 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Jul 30, 2024

Study contacts

Norhan Eltayeb, MSc candidate
Contact
1400534@st.pt.cu.edu.eg
01288053957
Nessrien AbdelRashid, assistant professor
Contact
nessrien.afify@pt.cu.edu.eg
01143872680

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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