Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

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: Charcot Foot Ulcer
• Intervention / Treatment: Device: pulsed electromagnetic field therapy; Device: Transcutanous electrical nerve stimulation; Drug: Vancomycin

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Norhan Eltayeb, MSc candidate; Phone Number: 01288053957; Email: 1400534@st.pt.cu.edu.eg
• Study Contact Backup: Name: Nessrien AbdelRashid, assistant professor; Phone Number: 01143872680; Email: nessrien.afify@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • physical therapy cairo University

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: Cairo University

Study record dates

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: Pathologic Processes; Skin Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Ulcer; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• 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