Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

NCT ID: NCT06527131

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Charcot Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A (Study group)

PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation

Group Type EXPERIMENTAL

pulsed electromagnetic field therapy

Intervention Type DEVICE

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 stimulation

Intervention Type DEVICE

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.

Group B(control group)

who recieves standard wound care , electrical stimulation and medical treatment

Group Type ACTIVE_COMPARATOR

Transcutanous electrical nerve stimulation

Intervention Type DEVICE

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.

Vancomycin

Intervention Type DRUG

medical antibiotics

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Vancomycin

medical antibiotics

Intervention Type DRUG

Other Intervention Names

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PEMF TENS

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Norhan Mohamed Eltayeb

Bachelor's degree, MSc candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Physical Therapy Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Norhan Eltayeb, MSc candidate

Role: CONTACT

01288053957

Nessrien AbdelRashid, assistant professor

Role: CONTACT

01143872680

Other Identifiers

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P.T.REC/012/005154

Identifier Type: -

Identifier Source: org_study_id

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