Chronic WoundsNCT05493943
P.E.M.F. Therapy of Chronic Wounds
A study testing Pulsed ElectroMagnetic Field (PEMF) therapy and Pulsed ElectroMagnetic (PEMF) therapy in people with Chronic Wounds, run by PEMF Systems, Inc..
Trial summary
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Pulsed ElectroMagnetic Field (PEMF) therapy and Pulsed ElectroMagnetic (PEMF) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2025
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth cannot be assessed by gross visual inspection is an exclusion.
Trial locations and contacts
No sites are listed yet.
About this study
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.
Read the detailed description
The goal of the three-arm trial is to employ application of pulsed electromagnetic fields (PEMF) directly over chronic wounds combined with standard of care local wound therapy (SOC). Three different PEMF devices, one a low power system (LP-PEMF), another a high power system (HP-PEMF) and the third a sham device that does not emit energy (S-PEMF) will be employed as adjuncts to standard wound care. The primary hypothesis to be tested is that exposure of wounds to one of the PEMF devices leads to significantly better and faster healing than the sham system.
Research Design:
An investigator initiated, prospective, double blinded parallel three arm treatment study. Subjects are randomized to receive one of the three PEMF devices (LP-PEMF, HP-PEMF or sham device) twice daily for 15 minutes directly over a wound. Initially, 40 subjects from each treatment group will be enrolled for total of 120 subjects at VA Long Beach Healthcare System (VALB) at the interim analysis. Based on the results of that analysis, one of the treatment arms will be eliminated and a follow-up study will continue with the remaining two arms. Additional 60 to 100 subjects are to be enrolled after interim analysis and the study may expand to Greater Los Angeles Medical Center. The study is expected to last 2 years.
Participating eligible subjects will be asked to come to the VALB once a week for 14 weeks and then for 2 or 3 visits over 8 more weeks. The total number of visits including the first visit could be up to 17 visits in 5 months. The study has three phases: Screening phase (2 weeks); Treatment phase (12 weeks); and Follow-up phase (8 weeks). Subjects participation in the study may last up to 22 weeks, but subjects who heal early during the Treatment phase will have a reduced period of participation based on when their wound heals.
Methodology
Inclusion criteria include age ≥21 years; presence of venous leg ulcers (VLU), Diabetic foot ulcers (DFU) or Pressure Ulcers (PU); wound size between 2 and 30 cm2; no exposed joint, tendon or bone, no tunneling or sinus tracts; wound duration ≥ 6 weeks.
Each wound will be reviewed for eligibility by assessing with duplex ultrasound, skin changes, tendon/bone/joint involvement, Ankle brachial Pressure Index (ABI), BMI, Hemoglobin A1c, Albumin and other medical history.
Female subjects who are currently breast feeding or capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).
Findings: None
Clinical Significance: Potentially beneficial treatment option for veterans with diabetic foot ulcer, venous leg ulcers or pressure ulcers.
- Conditions
- Chronic Wounds
- Being tested
- Pulsed ElectroMagnetic Field (PEMF) therapy, Pulsed ElectroMagnetic (PEMF) therapy
- Keywords
- wounds, chronic
- Medical subject headings
- Wounds and Injuries, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed ElectroMagnetic Field (PEMF) therapyDevice
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Pulsed ElectroMagnetic (PEMF) therapyOther
Control arm.
| Study group | Role | What they receive |
|---|---|---|
| PEMF low power | Active comparator | PEMF therapy using a device with low pulse intensity. Receives: Device: Pulsed ElectroMagnetic Field (PEMF) therapy |
| PEMF medium power | Active comparator | PEMF therapy using a medium pulse intensity. Receives: Device: Pulsed ElectroMagnetic Field (PEMF) therapy |
| PEMF Sham control | Sham comparator | Control arm using a sham PEMF device. Receives: Other: Pulsed ElectroMagnetic (PEMF) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing
Complete re-epithelization of wound
Measured: 12 weeks
Wound closure
Squared milimeters of wound closure
Measured: 12 weeks
Secondary outcomes (2)
Number and type of adverse events
Safety Endpoint
Measured: 12 weeks
Device effectiveness
Compare the rate of effectiveness between performance of the two PEMF power levels by measuring percentage of wound closure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms, 2 have PEMF devices, 1 Control with sham devices
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PEMF Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Long Beach Healthcare System, Southern California Institute for Research and Education
- Responsible party
- Sponsor
- Investigators
- Ian Gordon, MD, PhD, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493943
- Sponsor's protocol ID
- VA Protocol 5.9
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17519258Salzberg 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.
PubMed 7546114Sarma 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.
PubMed 9394172Bragin 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.
PubMed 25343187Cheing 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.
PubMed 24395219Hannemann 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.
PubMed 24895156Matic 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.
PubMed 18536960Stiller 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.
PubMed 1390143
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P.E.M.F. Therapy of Chronic Wounds
- ClinicalTrials.gov ID
- NCT05493943
- Acronym / sponsor ID
- VA Protocol 5.9
- Conditions
- Chronic Wounds
- Keywords
- wounds, chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- PEMF Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VA Long Beach Healthcare System, Southern California Institute for Research and Education
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2022 (actual)
- 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.
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.
Detailed description
The goal of the three-arm trial is to employ application of pulsed electromagnetic fields (PEMF) directly over chronic wounds combined with standard of care local wound therapy (SOC). Three different PEMF devices, one a low power system (LP-PEMF), another a high power system (HP-PEMF) and the third a sham device that does not emit energy (S-PEMF) will be employed as adjuncts to standard wound care. The primary hypothesis to be tested is that exposure of wounds to one of the PEMF devices leads to significantly better and faster healing than the sham system.
Research Design:
An investigator initiated, prospective, double blinded parallel three arm treatment study. Subjects are randomized to receive one of the three PEMF devices (LP-PEMF, HP-PEMF or sham device) twice daily for 15 minutes directly over a wound. Initially, 40 subjects from each treatment group will be enrolled for total of 120 subjects at VA Long Beach Healthcare System (VALB) at the interim analysis. Based on the results of that analysis, one of the treatment arms will be eliminated and a follow-up study will continue with the remaining two arms. Additional 60 to 100 subjects are to be enrolled after interim analysis and the study may expand to Greater Los Angeles Medical Center. The study is expected to last 2 years.
Participating eligible subjects will be asked to come to the VALB once a week for 14 weeks and then for 2 or 3 visits over 8 more weeks. The total number of visits including the first visit could be up to 17 visits in 5 months. The study has three phases: Screening phase (2 weeks); Treatment phase (12 weeks); and Follow-up phase (8 weeks). Subjects participation in the study may last up to 22 weeks, but subjects who heal early during the Treatment phase will have a reduced period of participation based on when their wound heals.
Methodology
Inclusion criteria include age ≥21 years; presence of venous leg ulcers (VLU), Diabetic foot ulcers (DFU) or Pressure Ulcers (PU); wound size between 2 and 30 cm2; no exposed joint, tendon or bone, no tunneling or sinus tracts; wound duration ≥ 6 weeks.
Each wound will be reviewed for eligibility by assessing with duplex ultrasound, skin changes, tendon/bone/joint involvement, Ankle brachial Pressure Index (ABI), BMI, Hemoglobin A1c, Albumin and other medical history.
Female subjects who are currently breast feeding or capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).
Findings: None
Clinical Significance: Potentially beneficial treatment option for veterans with diabetic foot ulcer, venous leg ulcers or pressure ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 3 arms, 2 have PEMF devices, 1 Control with sham devices
| Arm | Type | Receives |
|---|---|---|
| PEMF low power | Active comparator | Device: Pulsed ElectroMagnetic Field (PEMF) therapyPEMF therapy using a device with low pulse intensity. |
| PEMF medium power | Active comparator | Device: Pulsed ElectroMagnetic Field (PEMF) therapyPEMF therapy using a medium pulse intensity. |
| PEMF Sham control | Sham comparator | Other: Pulsed ElectroMagnetic (PEMF) therapyControl arm using a sham PEMF device. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth cannot be assessed by gross visual inspection is an exclusion.
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 |
|---|---|---|
| Pulsed ElectroMagnetic Field (PEMF) therapyApplication of PEMF using treatment coils in eproximity to the area where treatment is desired. | Device | PEMF low power, PEMF medium power |
| Pulsed ElectroMagnetic (PEMF) therapyControl arm. | Other | PEMF Sham control |
Primary outcome
Time to complete healing
Time frame: 12 weeks
Complete re-epithelization of wound
Wound closure
Time frame: 12 weeks
Squared milimeters of wound closure
2 secondary outcomes
Number and type of adverse events
Time frame: 12 weeks
Device effectiveness
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 17519258Fernandez 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.
- Background: PubMed 7546114Salzberg 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.
- Background: PubMed 9394172Sarma 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.
- Background: PubMed 25343187Bragin 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.
- Background: PubMed 24395219Cheing 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.
- Background: PubMed 24895156Hannemann 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.
- Background: PubMed 18536960Matic 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.
- Background: PubMed 1390143Stiller 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ian Gordon, MD, PhD principal investigator
VA Long Beach Healthcare System
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed ElectroMagnetic Field (PEMF) therapy and Pulsed ElectroMagnetic (PEMF) therapy in people with Chronic Wounds, run by PEMF Systems, Inc..
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Davis (818-943-5414, JMDavis@pemfsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05493943, which also lists 8 linked publications.
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 5 Apr 2024.