P.E.M.F. Therapy of Chronic Wounds
Primary Purpose
Chronic Wounds
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed ElectroMagnetic Field (PEMF) therapy
Pulsed ElectroMagnetic (PEMF) therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wounds focused on measuring wounds, chronic
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
PEMF low power
PEMF medium power
PEMF Sham control
Arm Description
PEMF therapy using a device with low pulse intensity.
PEMF therapy using a medium pulse intensity.
Control arm using a sham PEMF device.
Outcomes
Primary Outcome Measures
Time to complete healing
Complete re-epithelization of wound
Wound closure
Squared milimeters of wound closure
Secondary Outcome Measures
Number and type of adverse events
Safety Endpoint
Device effectiveness
Compare the rate of effectiveness between performance of the two PEMF power levels by measuring percentage of wound closure
Full Information
NCT ID
NCT05493943
First Posted
July 13, 2022
Last Updated
August 29, 2022
Sponsor
PEMF Systems, Inc.
Collaborators
VA Long Beach Healthcare System, Southern California Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT05493943
Brief Title
P.E.M.F. Therapy of Chronic Wounds
Official Title
P.E.M.F. Therapy of Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PEMF Systems, Inc.
Collaborators
VA Long Beach Healthcare System, Southern California Institute for Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds
Keywords
wounds, chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 arms, 2 have PEMF devices, 1 Control with sham devices
Masking
ParticipantCare Provider
Masking Description
Random, at time of enrollment
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEMF low power
Arm Type
Active Comparator
Arm Description
PEMF therapy using a device with low pulse intensity.
Arm Title
PEMF medium power
Arm Type
Active Comparator
Arm Description
PEMF therapy using a medium pulse intensity.
Arm Title
PEMF Sham control
Arm Type
Sham Comparator
Arm Description
Control arm using a sham PEMF device.
Intervention Type
Device
Intervention Name(s)
Pulsed ElectroMagnetic Field (PEMF) therapy
Intervention Description
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Intervention Type
Other
Intervention Name(s)
Pulsed ElectroMagnetic (PEMF) therapy
Intervention Description
Control arm.
Primary Outcome Measure Information:
Title
Time to complete healing
Description
Complete re-epithelization of wound
Time Frame
12 weeks
Title
Wound closure
Description
Squared milimeters of wound closure
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number and type of adverse events
Description
Safety Endpoint
Time Frame
12 weeks
Title
Device effectiveness
Description
Compare the rate of effectiveness between performance of the two PEMF power levels by measuring percentage of wound closure
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Davis
Phone
818-943-5414
Email
JMDavis@pemfsystems.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Ma, MD, MPH
Phone
562-826-8000
Ext
1-2889
Email
Christine.Ma@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Gordon, MD, PhD
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17519258
Citation
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.
Results Reference
background
PubMed Identifier
7546114
Citation
Salzberg 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.
Results Reference
background
PubMed Identifier
9394172
Citation
Sarma 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.
Results Reference
background
PubMed Identifier
25343187
Citation
Bragin 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.
Results Reference
background
PubMed Identifier
24395219
Citation
Cheing 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.
Results Reference
background
PubMed Identifier
24895156
Citation
Hannemann 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.
Results Reference
background
PubMed Identifier
18536960
Citation
Matic 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.
Results Reference
background
PubMed Identifier
1390143
Citation
Stiller 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.
Results Reference
background
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https://pubmed.ncbi.nlm.nih.gov/17519258/
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https://pubmed.ncbi.nlm.nih.gov/7546114/
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https://pubmed.ncbi.nlm.nih.gov/9394172/
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https://pubmed.ncbi.nlm.nih.gov/25343187/
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https://pubmed.ncbi.nlm.nih.gov/24395219/
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https://pubmed.ncbi.nlm.nih.gov/24895156/
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https://pubmed.ncbi.nlm.nih.gov/18536960/
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https://pubmed.ncbi.nlm.nih.gov/1390143/
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P.E.M.F. Therapy of Chronic Wounds
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