Status:
TERMINATED
The Effects of Pulsed Elelectro-Magnetic Fields ("PEMF") in the Treatment of Venous Stasis Leg Ulcers
Lead Sponsor:
PEMF Systems, Inc.
Collaborating Sponsors:
Henry Ford Health System
Conditions:
Venous Stasis Ulcers
Eligibility:
All Genders
21+ years
Brief 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 ulcer...
Detailed Description
This study will demonstrate whether PEMF therapy is an effective adjunct treatment to the traditional treatment protocol used for the resolution of VSLU and of the pain associated with them. This is a...
Eligibility Criteria
Inclusion
- Participants must also have normal cognitive and communicative abilities to provide comprehensive information for:
- 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
- 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
- Pregnancy - women of childbearing potential must agree to use adequate contraception during the study
- HIV infection unless on retroviral therapy and viral load undetectable by PCR
- Severe hypoxemia - chronic oxygen or ventilator therapy
- Known cryoglobulinemia
- Systemic antibiotic therapy for any indication within 5 days of screening
- A fracture to the lower extremities in the last 6 weeks
- Within 24 hours of any surgery or 2 weeks of surgery on internal organs
- Critically ill patients, patients hospitalized and patients who received transplants in past 2 months or patients in whom over-medication may be contraindicated
- Active chemotherapy, cancer or malignant tumors
- Any metal screws, pins and/or metallic implants within 15 inches of the VSLU
- Participants with specific ulcers originating from sickle cell anemia or clinically significant infections as determined by ulcer culture
- A history of difficult venipuncture for obtaining blood specimens
- Current use of systemic agents or immunosuppressive therapy that may influence wound healing, such as Prednisone, Dexamethasone. Topical steroids to a maximum level of 25 mg Hydrocortisone daily applied no closer than 2.5 cm from the VSLU margin. Non steroidal anti-inflammatory drugs (NSAIDs) are not allowed except Ibuprofen maximum daily dose of 1800 mg, Acetaminophen maximum daily dose of 2600 mg (with or w/o opiates) and Naproxen maximum daily dose of 1000 mg
- Current participation in any other clinical trial or study
- Current involvement in a medical litigation or malpractice lawsuit.
Key Trial Info
Start Date :
November 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03416049
Start Date
November 8 2018
End Date
January 20 2023
Last Update
April 5 2024
Active Locations (1)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202