NCT02145962

Brief Summary

An open multicenter trial to document the efficacy and safety of two therapeutic Extremely Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot Ulcers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

7.1 years

First QC Date

May 16, 2014

Last Update Submit

May 20, 2014

Conditions

Neuropathic Diabetic Ulcer - Foot

Keywords

diabetic foot ulcer healingmagnetic therapysafety and efficacywound care

Outcome Measures

Primary Outcomes (1)

  • Diabetic foot ulcer healing time

    Healing time was defined as the period (in days) required for the completion of ulcer closure when applying electromagnetic field treatment. Treatment period end-point was 14.2 weeks or upon complete healing according to clinical inspection.

    14.2 weeks or upon complete ulcer healing

Secondary Outcomes (1)

  • Adverse events

    Two periods: 1 year and up to 7 years

Study Arms (2)

Forearm tissue exposure with ELF-MF

ACTIVE COMPARATOR

This study arm should include subjects with diabetic foot ulcers recruited at the medical services site of the Autonomous University of Nuevo Leon, Monterrey, Mexico. These study patients should receive treatment in the forearm region.

Device: Forearm tissue exposure with ELF-MF

Thorax tissue exposure with ELF-MF

ACTIVE COMPARATOR

This study arm should include subjects with diabetic foot ulcers recruited at the IMSS Regional General Hospital N. 1 and Servicios de Salud de Morelos, Cuernavaca, Mexico. These study patients received treatment in the thorax region.

Device: Thorax tissue exposure with ELF-MF

Interventions

Forearm tissue exposure with ELF-MFDEVICE

The treatment was delivered 2 hours/day, 2 times/week and consisted of sinusoidal oscillating magnetic fields of 120 Hz using a solenoid, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the forearm device is approximately 30 ml/min or 3.6 lt/session.

Forearm tissue exposure with ELF-MF
Thorax tissue exposure with ELF-MFDEVICE

The treatment was delivered 25 minutes/day, 2 times/week and consisted of 120 Hz using a quasi-Helmholtz coil configuration, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the thorax device should be approximately 6,500 ml/min or 162.5 lt/session, which is approximately 45 times more blood volume stimulation per unit of time compared with the Forearm exposure system.

Thorax tissue exposure with ELF-MF

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 20 years old
  • Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
  • Medical care prior to admission.

You may not qualify if:

  • Pregnant women
  • Cancer diagnosis
  • BMI \> 3
  • Non-diabetic leg ulcers
  • Infected wounds
  • Skin autoimmune disease
  • Vasculitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital General Regional No. 1 "Ignacio García Tellez" IMSS

Cuernavaca, Morelos, 62450, Mexico

Location

Medical Services of the Autonomous University of Nuevo Leon

Monterrey, Nuevo León, 64000, Mexico

Location

Related Publications (1)

  • Canedo-Dorantes L, Garcia-Cantu R, Barrera R, Mendez-Ramirez I, Navarro VH, Serrano G. Healing of chronic arterial and venous leg ulcers through systemic effects of electromagnetic fields [corrected]. Arch Med Res. 2002 May-Jun;33(3):281-9. doi: 10.1016/s0188-4409(02)00357-0.

    PMID: 12031635BACKGROUND

Study Officials

  • Luis E Canedo Dorantes, MD, PhD

    Autonomous University of Morelos

    PRINCIPAL INVESTIGATOR

  • Guillermo Cabrera Alvarez, MD

    Instituto Mexicano del Seguro Social

    STUDY CHAIR

  • Rogelio Salinas Dominguez, MD

    Universidad Autonoma de Nuevo Leon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor, MD PhD

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 23, 2014

Study Start

December 1, 2006

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

ME(2)