P.E.M.F. Therapy of Chronic Wounds

April 3, 2024 updated by: PEMF Systems, Inc.
To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEMF low power
PEMF therapy using a device with low pulse intensity.
Device: Pulsed ElectroMagnetic Field (PEMF) therapy
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Active Comparator: PEMF medium power
PEMF therapy using a medium pulse intensity.
Device: Pulsed ElectroMagnetic Field (PEMF) therapy
Application of PEMF using treatment coils in eproximity to the area where treatment is desired.
Sham Comparator: PEMF Sham control
Control arm using a sham PEMF device.
Other: Pulsed ElectroMagnetic (PEMF) therapy
Control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete healing
Time Frame: 12 weeks
Complete re-epithelization of wound
12 weeks
Wound closure
Time Frame: 12 weeks
Squared milimeters of wound closure
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and type of adverse events
Time Frame: 12 weeks
Safety Endpoint
12 weeks
Device effectiveness
Time Frame: 12 weeks
Compare the rate of effectiveness between performance of the two PEMF power levels by measuring percentage of wound closure
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PEMF Systems, Inc.

Collaborators

Southern California Institute for Research and Education
VA Long Beach Healthcare System

Investigators

  • Principal Investigator: Ian Gordon, MD, PhD, VA Long Beach Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

August 6, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA Protocol 5.9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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