Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

July 28, 2024 updated by: Norhan Mohamed Eltayeb, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Study group)
PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation
Device: pulsed 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
Other Names:
  • PEMF
Device: Transcutanous 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.
Other Names:
  • TENS
Active Comparator: Group B(control group)
who recieves standard wound care , electrical stimulation and medical treatment
Device: Transcutanous 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.
Other Names:
  • TENS
Drug: Vancomycin
medical antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ulcrer healing
Time Frame: baseline and three months
asses wound surface area through wound surface area Tracing pre treatment ,after six weeks and after twelve weeks from initiation of treatment
baseline and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe