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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.
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| Lawrence A. Lavery, DPM, MPH | UNKNOWN |
| Kathryn Davis, Ph.D. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of BEST-induced perfusion effects | To compare the duration of BESTâ„¢ (Bio-Electric Stimulation Technology) induced perfusion effects | 3 hours |
| Changes in reported pain after BESTâ„¢ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence A Lavery, DPM, MPH | University of Texas Southwestern Medical Center, Department of Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center, Department of Plastic Surgery | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24049559 | Background | 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. | |
| 9798171 | 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. |
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| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable |
| 24 hours |
| 29738296 | 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. |
| 29357520 | 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. |