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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03843307
Other study ID # STU 042018-005
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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