Neuropathic Diabetic Ulcer - FootNCT02145962
Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.
A study testing Forearm tissue exposure with ELF-MF and Thorax tissue exposure with ELF-MF in people with Neuropathic Diabetic Ulcer - Foot, run by Autonomous University of Morelos at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuropathic Diabetic Ulcer - Foot
- What is being tested?
- Forearm tissue exposure with ELF-MF and Thorax tissue exposure with ELF-MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesMexico
- Study dates
- Dec 2006to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
- Medical care prior to admission.
Who cannot join
- Pregnant women
- Cancer diagnosis
- BMI > 3
- Non-diabetic leg ulcers
- Infected wounds
- Skin autoimmune disease
- Vasculitis
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital General Regional No. 1 "Ignacio García Tellez" IMSS
Cuernavaca, Morelos, 62450
Medical Services of the Autonomous University of Nuevo Leon
Monterrey, Nuevo León, 64000
About this study
Official title: Application of Extremely Low Frequency Electromagnetic Fields in the Cicatrization of Ulcers With Diabetic Origin as a Method of Preventive and Complementary Treatment
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.
Read the detailed description
An open multi center trial to document the systemic effects and safety of Extremely Low Frequency Electromagnetic Fields (ELF-MF) stimulation on healing of Diabetic Foot Ulcers (DFU). The study will be performed in two sites: Monterrey, Nuevo Leon, with patients from Medical Services of the Autonomous University of Nuevo León, and Cuernavaca, Morelos with patients from Regional General Hospital of Cuernavaca N. 1 IMSS, and Health Services of Morelos.
Two ELF-MF investigational exposure systems will be used to stimulate blood at different anatomical regions to enhance wound healing upon peripheral blood mononuclear cell migration to the ulcer site. a) In Monterrey, Nuevo Leon, where DFU subjects should be exposed at either forearm with a sinusoidal oscillating magnetic field of 120 Hz with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS 2 hours/day, 2 times/week. and b) In Cuernavaca, Morelos, where DFU subjects would be exposed at the thorax with a stimulation system in a quasi-Helmholtz configuration, for 25 minutes/day, 2 times/week to a sinusoidal oscillating magnetic field of 120 Hz, with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS. Treatment period for both groups will be 14.2 weeks or upon a complete healing. In each treatment session, evolution of ulcer healing should be recorded photographically.
Efficacy and adverse effects will be searched for during treatment, short-term (<1 year), and long-term follow-up in both groups (up to 7 years).
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Being tested
- Forearm tissue exposure with ELF-MF, Thorax tissue exposure with ELF-MF
- Keywords
- diabetic foot ulcer healing, magnetic therapy, safety and efficacy, wound care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Thorax tissue exposure with ELF-MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14.2 weeks or upon complete ulcer healing
Secondary outcomes (1)
Adverse events
After treatment, follow-ups were performed to assess short-term (<1 year) and long-term safety (up to 7 years) after treatment. Adverse events were also assessed and defined as: a) Ulcer recurrences in the same site, b) Damage to an organ, c) Development of cancer or any other disease states possibly associated to the use of Extremely Low Frequency Magnetic Fields treatment.
Measured: Two periods: 1 year and up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startDec 2006
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Diabetic Ulcer - FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autonomous University of Morelos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Nuevo Leon, Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Luis Enrique Alberto Cañedo Dorantes, Autonomous University of Morelos
- Investigators
- Luis E Canedo Dorantes, MD, PhD, Principal investigator, Autonomous University of MorelosGuillermo Cabrera Alvarez, MD, Study chair, Instituto Mexicano del Seguro SocialRogelio Salinas Dominguez, MD, Study chair, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145962
- Sponsor's protocol ID
- ELF-MF-2006-001
- Other IDs
- AVANCE-C2005-219
- Status last verified
- May 2014
- First submitted
- 16 May 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12031635
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Extremely Low Frequency Electromagnetic Fields in the Cicatrization of Ulcers With Diabetic Origin as a Method of Preventive and Complementary Treatment
- ClinicalTrials.gov ID
- NCT02145962
- Acronym / sponsor ID
- ELF-MF-2006-001
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Keywords
- diabetic foot ulcer healing, magnetic therapy, safety and efficacy, wound care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Autonomous University of MorelosUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Nuevo Leon, Instituto Mexicano del Seguro Social
- Study start
- Dec 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An open multi center trial to document the systemic effects and safety of Extremely Low Frequency Electromagnetic Fields (ELF-MF) stimulation on healing of Diabetic Foot Ulcers (DFU). The study will be performed in two sites: Monterrey, Nuevo Leon, with patients from Medical Services of the Autonomous University of Nuevo León, and Cuernavaca, Morelos with patients from Regional General Hospital of Cuernavaca N. 1 IMSS, and Health Services of Morelos.
Two ELF-MF investigational exposure systems will be used to stimulate blood at different anatomical regions to enhance wound healing upon peripheral blood mononuclear cell migration to the ulcer site. a) In Monterrey, Nuevo Leon, where DFU subjects should be exposed at either forearm with a sinusoidal oscillating magnetic field of 120 Hz with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS 2 hours/day, 2 times/week. and b) In Cuernavaca, Morelos, where DFU subjects would be exposed at the thorax with a stimulation system in a quasi-Helmholtz configuration, for 25 minutes/day, 2 times/week to a sinusoidal oscillating magnetic field of 120 Hz, with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS. Treatment period for both groups will be 14.2 weeks or upon a complete healing. In each treatment session, evolution of ulcer healing should be recorded photographically.
Efficacy and adverse effects will be searched for during treatment, short-term (<1 year), and long-term follow-up in both groups (up to 7 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forearm tissue exposure with ELF-MF | Active comparator | Device: Forearm tissue exposure with ELF-MFThis 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. |
| Thorax tissue exposure with ELF-MF | Active comparator | Device: Thorax tissue exposure with ELF-MFThis 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
- Medical care prior to admission.
Key exclusion criteria (7 listed)
- Pregnant women
- Cancer diagnosis
- BMI > 3
- Non-diabetic leg ulcers
- Infected wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm tissue exposure with ELF-MFThe 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. | Device | Forearm tissue exposure with ELF-MF |
| Thorax tissue exposure with ELF-MFThe 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. | Device | Thorax tissue exposure with ELF-MF |
Primary outcome
Diabetic foot ulcer healing time
Time frame: 14.2 weeks or upon complete ulcer healing
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.
1 secondary outcome
Adverse events
Time frame: Two periods: 1 year and up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Background: PubMed 12031635Canedo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis E Canedo Dorantes, MD, PhD principal investigator
Autonomous University of Morelos
Guillermo Cabrera Alvarez, MD study chair
Instituto Mexicano del Seguro Social
Rogelio Salinas Dominguez, MD study chair
Universidad Autonoma de Nuevo Leon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm tissue exposure with ELF-MF and Thorax tissue exposure with ELF-MF in people with Neuropathic Diabetic Ulcer - Foot, run by Autonomous University of Morelos at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic foot ulcer healing time (time frame: 14.2 weeks or upon complete ulcer healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02145962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.