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

NCT03416049 | Terminated

• 1 other identifier: PEMF 102
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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 ulcers resulting from venous stasis ("VSLU").

Conditions

Venous Stasis Ulcers

Keywords

ulcers; leg ulcers; venous stasis; ulcer treatment; leg ulcer treatment; venous stasis treatment; non invasive treatment; pulsed electromagnetic; pulsed electromagnetic therapy; pulsed electromagnetic treatment; pulsed magnetic; pulsed magnetic therapy; pulsed magnetic treatment; varicose Ulcer; ulcer pain

Outcome Measures

Primary Outcomes (1)

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

  The healing trajectory will be evaluated after 16 weeks of PEMF treatment with one of three PEMF devices of different power level or a sham device. Leg ulcer area will be documented and a healing timeline will be defined. If healing is complete prior to the end of the 16-week treatment protocol, the RA will compile the length of time required for healing.

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

Secondary Outcomes (2)

• Blood and serum levels of three inflammatory cytokines are affected by the use of specific pulsed electromagnetic fields.

  The blood and serum samples are collected over 16 weeks

• Venous leg ulcer pain is affected by the use of specific pulsed electromagnetic fields.

  The assessments are collected over 16 weeks

Study Arms (4)

High-power PEMF device

20 participants with VSLU will receive PEMF therapy with a high-power PEMF device for 10 minutes twice a day for each VSLU area.

Device: PEMF therapy with a high-power PEMF device

Medium-power PEMF device

20 participants with VSLU will receive PEMF therapy with a medium-power PEMF device for 15 minutes twice a day per VSLU area.

Device: PEMF therapy with a medium PEMF power device

Low-power PEMF device

20 participants with VSLU will receive PEMF therapy with a low-power PEMF device for 30 minutes twice a day per VSLU area..

Device: PEMF therapy with a low-power PEMF device

Sham PEMF device

20 participants with VSLU will receive PEMF therapy with a sham PEMF device identical to the low-power PEMF device and will treat each VSLU area for 15 minutes twice a day.

Device: PEMF therapy with the sham PEMF device

Interventions

PEMF therapy with a high-power PEMF device DEVICE

The 20 participants assigned to a high-power PEMF device will treat each Venous Stasis Leg Ulcer (VSLU) area for 10 minutes twice a day.

Also known as: PEMF therapy with the Regenetron Pro, A, B, C, D

High-power PEMF device

PEMF therapy with a medium PEMF power device DEVICE

The 20 participants assigned to a medium-power PEMF device will treat each VSLU area for 15 minutes twice a day.

Also known as: PEMF therapy with the Regenetron Plus, A, B, C, D

Medium-power PEMF device

PEMF therapy with a low-power PEMF device DEVICE

The 20 participants assigned to a low-power PEMF device will treat each VSLU area for 30 minutes twice a day.

Also known as: PEMF therapy with the Regenetron, A, B, C, D

Low-power PEMF device

PEMF therapy with the sham PEMF device DEVICE

The 20 participants assigned to the sham PEMF device will treat each VSLU area for 15 minutes twice a day.

Also known as: PEMF therapy with the Regenetron sham, A, B, C, D

Sham PEMF device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participant population to be selected and studied will include male and female patients of all ethnic backgrounds ages 21 and older with one or more venous stasis leg ulcers (VSLU).

You may qualify if:

• 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©)

You may not qualify if:

• 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

Sponsors & Collaborators

• PEMF Systems, Inc.: lead
• Henry Ford Health System: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (11)

• Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J. 2009 Mar-Apr;29(2):135-43. doi: 10.1016/j.asj.2009.02.001.

  PMID: 19371845 BACKGROUND

• Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.

  PMID: 20527063 BACKGROUND

• Stiller MJ, Pak GH, Shupack JL, Thaler S, Kenny C, Jondreau L. A portable pulsed electromagnetic field (PEMF) device to enhance healing of recalcitrant venous ulcers: a double-blind, placebo-controlled clinical trial. Br J Dermatol. 1992 Aug;127(2):147-54. doi: 10.1111/j.1365-2133.1992.tb08047.x.

  PMID: 1390143 BACKGROUND

• Duran V, Zamurovic A, Stojanovic S, Poljacki M, Jovanovic M, Durisic S. [Therapy of venous ulcers using pulsating electromagnetic fields--personal results]. Med Pregl. 1991;44(11-12):485-8. Croatian.

  PMID: 1821449 BACKGROUND

• Athanasiou A, Karkambounas S, Batistatou A, Lykoudis E, Katsaraki A, Kartsiouni T, Papalois A, Evangelou A. The effect of pulsed electromagnetic fields on secondary skin wound healing: an experimental study. Bioelectromagnetics. 2007 Jul;28(5):362-8. doi: 10.1002/bem.20303.

  PMID: 17486634 BACKGROUND

• Itoh M, Montemayor JS Jr, Matsumoto E, Eason A, Lee MH, Folk FS. Accelerated wound healing of pressure ulcers by pulsed high peak power electromagnetic energy (Diapulse). Decubitus. 1991 Feb;4(1):24-5, 29-34.

  PMID: 1994961 BACKGROUND

• Ieran M, Zaffuto S, Bagnacani M, Annovi M, Moratti A, Cadossi R. Effect of low frequency pulsing electromagnetic fields on skin ulcers of venous origin in humans: a double-blind study. J Orthop Res. 1990 Mar;8(2):276-82. doi: 10.1002/jor.1100080217.

  PMID: 2303961 BACKGROUND

• Alekseenko AV, Gusak VV. [Treatment of trophic ulcers of the lower extremities using a magnetic field]. Klin Khir (1962). 1991;(7):60-3. Russian.

  PMID: 1942838 BACKGROUND

• Kuliev RA, Babaev RF. [A magnetic field in the combined treatment of suppurative wounds in diabetes mellitus]. Vestn Khir Im I I Grek. 1992 Jan;148(1):33-6. Russian.

  PMID: 1338829 RESULT

• Alekseenko AV, Gusak VV, Stoliar VF, Iftodii AG, Tarabanchuk VV, Shcherban NG, Naumets AA. [Use of magnetic therapy combined with galvanization and tissue electrophoresis in the treatment of trophic ulcers]. Klin Khir (1962). 1993;(7-8):31-4. Russian.

  PMID: 8139189 RESULT

• Comorosan S, Vasilco R, Arghiropol M, Paslaru L, Jieanu V, Stelea S. The effect of diapulse therapy on the healing of decubitus ulcer. Rom J Physiol. 1993 Jan-Jun;30(1-2):41-5.

  PMID: 7982015 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ulcer fluid .5 ml and blood 5 ml samples will be obtained for the following tests: Transforming Growth Factor ("TGF") Vascular Endothelial Growth Factor ("VEGF") Matrix Metalloroteinase ("MMP"), MMP-9 and MMP-13 Tumor Necrosis Factor alpha ("TNFα") Pro-inflammatory Cytokines: IL-1 α /IL-1F1 and IL-6

MeSH Terms

Conditions

Varicose Ulcer; Ulcer; Leg Ulcer

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Aamir Siddiqui, MD

  Division Head, Plastic Surgery, Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• Guillemette Epailly, BS, MArch

  PEMF Systems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: January 30, 2018
• Study Start: November 8, 2018
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)