TerminatedNot Applicable

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

Stopped: Dr. Siddiqui, the principal investigator, was unable to continue recruiting during and after covid.

United States33 participantsStarted 2018-11-08

Plain-language summary

The purpose of this study is to determine the clinical effectiveness of a low-power PEMF device, a medium-power PEMF device and a high-power PEMF device as compared to a sham device to treat leg ulcers resulting from venous stasis ("VSLU").

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Health history questionnaire and Your Health in General ("SF-36")
✓. The National Initiative on Pain Control pain assessment scales (NIPC scales). The NIPC scales are comprised of four complementary pain assessment rating scales, the Wong-Baker FACES Pain Rating Scale, Numeric Rating Scale (NRS), a pain location chart and a Pain Quality Assessment Scale© (PQAS©)

Exclusion criteria

✕. Inability to obtain informed consent from participant
✕. Prisoners or convicts
✕. Hemorrhagic tendencies, Purpura, hemophilia, or any cardiovascular diseases
✕. Severe anemia, Hemoglobin \< 8.5
✕. Severe hypoalbumenemia, serum albumen , 2.6
✕. Poorly controlled diabetes, A1cHgb \> 12
✕. Severe renal failure - serum creatinine \> 2.5 or hemodialysis
✕. Severe hepatic insufficiency: know cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal

What they're measuring

Specific pulsed electromagnetic fields improves the healing trajectory of venous stasis ulcers.

Timeframe: The data necessary to establish the healing trajectory is collected over 16 weeks

Trial details

NCT IDNCT03416049

SponsorPEMF Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-01-20

View on ClinicalTrials.gov More Venous Stasis Ulcers trials