Perfusion; ComplicationsNCT03843307
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
A study testing Avazzia Tennant Biomodulator® PRO in people with Perfusion; Complications and Wound; Foot, run by Avazzia, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Perfusion; Complications, Wound; Foot
- What is being tested?
- Avazzia Tennant Biomodulator® PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, 75390
About this study
Official title: Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
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
- Being tested
- Avazzia Tennant Biomodulator® PRO
- Keywords
- Electrical stimulation, Perfusion, Foot wound, Foot pain
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avazzia Tennant Biomodulator® PRODevice
High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | Not described Receives: Device: Avazzia Tennant Biomodulator® PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in perfusion up to 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
Measured: 3 hours
Improvement in perfusion up to 3 hours
Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)
Measured: 3 hours
Secondary outcomes (2)
Duration of BEST-induced perfusion effects
To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects
Measured: 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
Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start24 Apr 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: Due to difficulties with enrollment which were complicated by pauses to clinical research from COVID, The University of Texas Southwestern has decided not to pursue the continuation of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perfusion; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avazzia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center, Lawrence A. Lavery, DPM, MPH, Kathryn Davis, Ph.D.
- Responsible party
- Sponsor
- Investigators
- Lawrence A Lavery, DPM, MPH, Principal investigator, University of Texas Southwestern Medical Center, Department of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843307
- Sponsor's protocol ID
- STU 042018-005
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 24049559Peters 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.
PubMed 9798171Nair 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.
PubMed 29738296Andrushko 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.
PubMed 29357520
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
- ClinicalTrials.gov ID
- NCT03843307
- Acronym / sponsor ID
- STU 042018-005
- Conditions
- Perfusion; Complications, Wound; Foot
- Keywords
- Electrical stimulation, Perfusion, Foot wound, Foot pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulties with enrollment which were complicated by pauses to clinical research from COVID, The University of Texas Southwestern has decided not to pursue the continuation of this study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Avazzia, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center, Lawrence A. Lavery, DPM, MPH, Kathryn Davis, Ph.D.
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Device: Avazzia Tennant Biomodulator® PRO |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avazzia Tennant Biomodulator® PROHigh-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics. | Device | Electrical stimulation |
Primary outcome
Improvement in perfusion up to 3 hours
Time frame: 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
Improvement in perfusion up to 3 hours
Time frame: 3 hours
Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)
2 secondary outcomes
Duration of BEST-induced perfusion effects
Time frame: 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
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Due to difficulties with enrollment which were complicated by pauses to clinical research from COVID, The University of Texas Southwestern has decided not to pursue the continuation of this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 24049559Thakral 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.
- Background: PubMed 9798171Peters 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.
- Background: PubMed 29738296Nair 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.
- Background: PubMed 29357520Andrushko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence A Lavery, DPM, MPH principal investigator
University of Texas Southwestern Medical Center, Department of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avazzia Tennant Biomodulator® PRO in people with Perfusion; Complications and Wound; Foot, run by Avazzia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to difficulties with enrollment which were complicated by pauses to clinical research from COVID, The University of Texas Southwestern has decided not to pursue the continuation of this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in perfusion up to 3 hours (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843307, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.