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NCT Number: NCT06527131

Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

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

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Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Cairo University

Giza, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Electromagnetic Field Therapy

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

Other names: PEMF

Transcutanous electrical nerve stimulation

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.

Other names: TENS

Vancomycin

Drug

medical antibiotics

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nessrien AbdelRashid, assistant professor

CONTACT

[email protected]

01143872680

Norhan Eltayeb, MSc candidate

CONTACT

[email protected]

01288053957

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.