P.E.M.F. Therapy of Chronic Wounds
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 5, 2024
April 1, 2024
8 months
July 13, 2022
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to complete healing
Complete re-epithelization of wound
12 weeks
Wound closure
Squared milimeters of wound closure
12 weeks
Secondary Outcomes (2)
Number and type of adverse events
12 weeks
Device effectiveness
12 weeks
Study Arms (3)
PEMF low power
ACTIVE COMPARATORPEMF therapy using a device with low pulse intensity.
PEMF medium power
ACTIVE COMPARATORPEMF therapy using a medium pulse intensity.
PEMF Sham control
SHAM COMPARATORControl arm using a sham PEMF device.
Interventions
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Eligibility Criteria
You may qualify if:
- Age must be at least 21 years old at the time of signing consent. 8.2 The index study ulcer size must be between 2.0 and 30.0 cm2 at the time of randomization. Measurements and photographs will to be taken after sharp debridement if performed at the Randomization Visit.
- The index ulcer must have been present for at least 6 weeks prior to randomization.
- If more than one ulcer is present on the target limb, the largest eligible ulcer should be deemed the study ulcer. Other ulcers close to the study ulcer are allowed and may be of any size. However, they should be \> 2cm away from the study ulcer. Ulcers are allowed at other locations such as the on the contralateral limb. Other ulcers present besides the index study wound can be treated with different local care but cannot be treated with the PEMF device.
- Only one site of application of the PEMF device is allowed and the PEMF device must be placed directly over the study ulcer.
- Subjects to be enrolled into the VLU group must have had a duplex ultrasound study (if not done within six months prior the first screening visit) to document venous disease (deep system obstruction or reflux \> 0.5 sec, or superficial system reflux \> 0.5 sec, or have the characteristic hyperpigmentation and skin changes (lipodermatosclerosis) typical of venous disease.
- Diabetic Foot Ulcer (DFU): Subjects should have with neuropathy demonstrated by monofilament testing and have Wagner grade 1 wounds without involvement of tendon, bone, or joint.
- Pressure Ulcer (PU): PU subject wounds must be stage 3 without deep structure involvement such as bone, tendon, or joint.
You may not qualify if:
- Wounds due to autoimmune disease such as rheumatoid arthritis or vasculitis.
- Exposed structures deep to the adipose layer of skin such as muscle, fascia, tendon, joint, or bone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PEMF Systems, Inc.lead
- VA Long Beach Healthcare Systemcollaborator
- Southern California Institute for Research and Educationcollaborator
Related Publications (8)
Fernandez MI, Watson PJ, Rowbotham DJ. Effect of pulsed magnetic field therapy on pain reported by human volunteers in a laboratory model of acute pain. Br J Anaesth. 2007 Aug;99(2):266-9. doi: 10.1093/bja/aem129. Epub 2007 May 22.
PMID: 17519258BACKGROUNDSalzberg CA, Cooper-Vastola SA, Perez F, Viehbeck MG, Byrne DW. The effects of non-thermal pulsed electromagnetic energy on wound healing of pressure ulcers in spinal cord-injured patients: a randomized, double-blind study. Ostomy Wound Manage. 1995 Apr;41(3):42-4, 46, 48 passim.
PMID: 7546114BACKGROUNDSarma GR, Subrahmanyam S, Deenabandhu A, Babu CR, Madhivathanan S, Kesavaraj N. Exposure to pulsed magnetic fields in the treatment of plantar ulcers in leprosy patients--a pilot, randomized, double-blind, controlled clinical trial. Indian J Lepr. 1997 Jul-Sep;69(3):241-50.
PMID: 9394172BACKGROUNDBragin DE, Statom GL, Hagberg S, Nemoto EM. Increases in microvascular perfusion and tissue oxygenation via pulsed electromagnetic fields in the healthy rat brain. J Neurosurg. 2015 May;122(5):1239-47. doi: 10.3171/2014.8.JNS132083. Epub 2014 Oct 24.
PMID: 25343187BACKGROUNDCheing GL, Li X, Huang L, Kwan RL, Cheung KK. Pulsed electromagnetic fields (PEMF) promote early wound healing and myofibroblast proliferation in diabetic rats. Bioelectromagnetics. 2014 Apr;35(3):161-9. doi: 10.1002/bem.21832. Epub 2014 Jan 3.
PMID: 24395219BACKGROUNDHannemann PF, Mommers EH, Schots JP, Brink PR, Poeze M. The effects of low-intensity pulsed ultrasound and pulsed electromagnetic fields bone growth stimulation in acute fractures: a systematic review and meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2014 Aug;134(8):1093-106. doi: 10.1007/s00402-014-2014-8. Epub 2014 Jun 4.
PMID: 24895156BACKGROUNDMatic M, Lazetic B, Poljacki M, Djuran V, Matic A, Gajinov Z. Influence of different types of electromagnetic fields on skin reparatory processes in experimental animals. Lasers Med Sci. 2009 May;24(3):321-7. doi: 10.1007/s10103-008-0564-0. Epub 2008 Jun 7.
PMID: 18536960BACKGROUNDStiller MJ, Pak GH, Shupack JL, Thaler S, Kenny C, Jondreau L. A portable pulsed electromagnetic field (PEMF) device to enhance healing of recalcitrant venous ulcers: a double-blind, placebo-controlled clinical trial. Br J Dermatol. 1992 Aug;127(2):147-54. doi: 10.1111/j.1365-2133.1992.tb08047.x.
PMID: 1390143BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Gordon, MD, PhD
VA Long Beach Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Random, at time of enrollment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
August 9, 2022
Study Start
May 1, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
April 5, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share