Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study

Perfusion; Complications Clinical Trial

Official title:

Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03843307
• Other study ID #: STU 042018-005
• Status: Terminated
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: April 12, 2021

Study information

• Verified date: August 2021
• Source: Avazzia, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to improve perfusion in the treated and contralateral limb.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Able to provide Informed Consent
• Ankle Brachial Index (ABI) = 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to therapy)
• Participant is a hospital in-patient for the duration of study procedures
• One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
• 18 years of age or older

Exclusion Criteria:

• Unable to provide informed consent
• <18 years of age
• Participant has a demand-type cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device.
• Participant has untreated osteomyelitis
• Participant has active cellulitis
• Participant has active charcot
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the participant's ability to provide informed consent, participate in the study protocol including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.

Related Conditions & MeSH terms

• Foot Injuries
• Perfusion; Complications
• Wound; Foot

Intervention

Device:
• Avazzia Tennant Biomodulator® PRO
High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center, Department of Plastic Surgery	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Avazzia, Inc	Kathryn Davis, Ph.D., Lawrence A. Lavery, DPM, MPH, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Andrushko JW, Lanovaz JL, Björkman KM, Kontulainen SA, Farthing JP. Unilateral strength training leads to muscle-specific sparing effects during opposite homologous limb immobilization. J Appl Physiol (1985). 2018 Apr 1;124(4):866-876. doi: 10.1152/japplphysiol.00971.2017. Epub 2017 Dec 14. — View Citation

Nair HKR. Microcurrent as an adjunct therapy to accelerate chronic wound healing and reduce patient pain. J Wound Care. 2018 May 2;27(5):296-306. doi: 10.12968/jowc.2018.27.5.296. — View Citation

Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. — View Citation

Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in perfusion up to 3 hours	Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)	3 hours
Primary	Improvement in perfusion up to 3 hours	Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)	3 hours
Secondary	Duration of BEST-induced perfusion effects	To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects	3 hours
Secondary	Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment	Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable	24 hours