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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To measure the effectiveness of pulsed electromagnetic fields (PEMF) as an adjunct wound care therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

NCT01561170

Chronic Venous Hypertension With Ulcer and Inflammation Venous Ulcer Pain

UNKNOWN

Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.

NCT02145962

Neuropathic Diabetic Ulcer - Foot

COMPLETED NA

PEMF Effects on Pain After Abdominal Body Contouring

NCT01762423

Abdominal Body Contouring Surgery Postoperative Pain

WITHDRAWN PHASE4

Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

NCT01842204

Inguinal Hernias

COMPLETED NA

The Effects of Pulsed Elelectro-Magnetic Fields ("PEMF") in the Treatment of Venous Stasis Leg Ulcers

NCT03416049

Venous Stasis Ulcers

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Wounds

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 arms, 2 have PEMF devices, 1 Control with sham devices

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Random, at time of enrollment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEMF low power

PEMF therapy using a device with low pulse intensity.

Group Type ACTIVE_COMPARATOR

Pulsed ElectroMagnetic Field (PEMF) therapy

Intervention Type DEVICE

Application of PEMF using treatment coils in eproximity to the area where treatment is desired.

PEMF medium power

PEMF therapy using a medium pulse intensity.

Group Type ACTIVE_COMPARATOR

Pulsed ElectroMagnetic Field (PEMF) therapy

Intervention Type DEVICE

Application of PEMF using treatment coils in eproximity to the area where treatment is desired.

PEMF Sham control

Control arm using a sham PEMF device.

Group Type SHAM_COMPARATOR

Pulsed ElectroMagnetic (PEMF) therapy

Intervention Type OTHER

Control arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulsed ElectroMagnetic Field (PEMF) therapy

Application of PEMF using treatment coils in eproximity to the area where treatment is desired.

Intervention Type DEVICE

Pulsed ElectroMagnetic (PEMF) therapy

Control arm.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No