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

NCT03843307 | Terminated FDA Device

• 1 other identifier: STU 042018-005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perfusion; Complications; Wound; Foot

Keywords

Electrical stimulation; Perfusion; Foot wound; Foot pain

Outcome Measures

Primary Outcomes (2)

• Improvement in perfusion up to 3 hours

  Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)

  3 hours

• Improvement in perfusion up to 3 hours

  Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)

  3 hours

Secondary Outcomes (2)

• Duration of BEST-induced perfusion effects

  3 hours

• Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment

  24 hours

Study Arms (1)

Electrical stimulation

EXPERIMENTAL

Device: Avazzia Tennant Biomodulator® PRO

Interventions

Avazzia Tennant Biomodulator® PRO DEVICE

High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.

Electrical stimulation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avazzia, Inc: lead
• University of Texas Southwestern Medical Center: collaborator
• Lawrence A. Lavery, DPM, MPH: collaborator
• Kathryn Davis, Ph.D.: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center, Department of Plastic Surgery

Dallas, Texas, 75390, United States

Location

Related Publications (4)

• 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.

  PMID: 24049559 BACKGROUND

• 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. doi: 10.1016/s1067-2516(98)80048-3.

  PMID: 9798171 BACKGROUND

• 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.

  PMID: 29738296 BACKGROUND

• Andrushko JW, Lanovaz JL, Bjorkman 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.

  PMID: 29357520 BACKGROUND

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Lawrence A Lavery, DPM, MPH

  University of Texas Southwestern Medical Center, Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 18, 2019
• Study Start: April 24, 2019
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

US (1)