Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

NCT06527131 | Recruiting

• 1 other identifier: P.T.REC/012/005154
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Charcot Foot Ulcer

Outcome Measures

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

  Baseline and three months

Secondary Outcomes (1)

• ulcrer healing

  baseline and three months

Study Arms (2)

Group A (Study group)

EXPERIMENTAL

PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation

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

Group B(control group)

ACTIVE COMPARATOR

who recieves standard wound care , electrical stimulation and medical treatment

Device: Transcutanous electrical nerve stimulation; Drug: Vancomycin

Interventions

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

Also known as: PEMF

Group A (Study group)

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.

Also known as: TENS

Group A (Study group); Group B(control group)

Vancomycin DRUG

medical antibiotics

Group B(control group)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation; Vancomycin

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Norhan Eltayeb, MSc candidate

CONTACT

01288053957; 1400534@st.pt.cu.edu.eg

Nessrien AbdelRashid, assistant professor

CONTACT

01143872680; nessrien.afify@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's degree, MSc candidate

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)