An interventional study of Pulsed ElectroMagnetic Field (PEMF) therapy and Pulsed ElectroMagnetic (PEMF) therapy in Chronic Wounds, sponsored by PEMF Systems, Inc.. Not yet recruiting. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by PEMF Systems, Inc. · Not applicable, Interventional, and Treatment
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →PEMF Systems, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
PEMF therapy using a device with low pulse intensity.
Device: Pulsed ElectroMagnetic Field (PEMF) therapy
PEMF therapy using a medium pulse intensity.
Device: Pulsed ElectroMagnetic Field (PEMF) therapy
Control arm using a sham PEMF device.
Other: Pulsed ElectroMagnetic (PEMF) therapy
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Control arm.
Time to complete healing
Complete re-epithelization of wound
Time frame: 12 weeks
Wound closure
Squared milimeters of wound closure
Time frame: 12 weeks
Number and type of adverse events
Safety Endpoint
Time frame: 12 weeks
Device effectiveness
Compare the rate of effectiveness between performance of the two PEMF power levels by measuring percentage of wound closure
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PEMF Systems, Inc.