Clinical trial NCT03843307: Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
Official title: Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Perfusion; Complications
Wound; Foot
Keywords: Electrical stimulation
Perfusion
Foot wound
Foot pain
Lead sponsor: Avazzia, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Texas Southwestern Medical Center
name: Lawrence A. Lavery, DPM, MPH
name: Kathryn Davis, Ph.D.
First posted: 2019-02-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in perfusion up to 3 hours
timeFrame: 3 hours
measure: Improvement in perfusion up to 3 hours
timeFrame: 3 hours
Secondary outcomes:
measure: Duration of BEST-induced perfusion effects
timeFrame: 3 hours
measure: Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Department of Plastic Surgery
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center, Department of Plastic Surgery
name: Lawrence A Lavery, DPM, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/s1067-2516(98)80048-3.
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.
citation: 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.