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AVAZZIA Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT03821675
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Avazzia, Inc
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Study Description
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Brief Summary:
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound healing, relieve pain and improve mobility in patients with diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetes Diabetic Foot Ulcer Peripheral Neuropathy Peripheral Arterial Disease Device: Electrical Stimulation Device: Electrical Stimulation - Sham Phase 2 Phase 3

Detailed Description:

Electrical stimulation may offer a unique treatment option to heal complicated and recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound healing.

Electrical stimulation could have positive effect on not only increasing skin perfusion in patients with diabetes but also could improve mobility and balance via enhancing plantar sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may assist to improve mobility and reduce the likelihood of recurrence of ulcers.

This study is proposed to examine the effectiveness of an innovative portable electrical stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion, reduce pain, and improve balance and mobility in DFU patients (long term benefit)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Devices may be active or sham.
Primary Purpose: Supportive Care
Official Title: ELECTRICAL STIMULATION AS AN ADJUNCTIVE THERAPY TO ACCELERATE WOUND HEALING IN PEOPLE WITH DIABETIC FOOT ULCERS - A RANDOMIZED CONTROLLED TRIAL
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
 Device: Electrical Stimulation
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Sham Comparator: Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
 Device: Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in skin perfusion after at least 30 minutes lower extremities electrical stimulation therapy [ Time Frame: before applying electrical stimulation (baseline), immediately after 30 minutes and 60 minutes application ]
    change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)

  2. Change in self-reported pain at every week [ Time Frame: baseline to 4 weeks ]
    Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.

  3. Change in self-reported pain during dress change at every week [ Time Frame: baseline to 4 weeks ]
    Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.

  4. Change in skin perfusion at baseline and 4 weeks [ Time Frame: baseline to 4 weeks ]
    skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)

  5. Change in number of steps at baseline and 4 weeks [ Time Frame: baseline to 4 weeks ]
    Change will be assessed using a physical activity monitor

  6. Change in wound size from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    wound size will be quantified using wound imaging systems


Secondary Outcome Measures :
  1. change in plantar sensation from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    plantar sensation will be quantified using a neurothesiometer

  2. Change in sedentary behavior from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    sedentary behavior will be defined as percentage time spent sitting/lying for 48 hours using an activity monitor (PAMSys, Biosensics)

  3. change in gait speed from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    gait speed will be quantified using a validated wearable platform (LEGySys, Biosensics)

  4. change in balance from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    balance will be quantified using a validated wearable platform (BalanSens, Biosensics)

  5. Change in tissue oxygenation after at least 30 minutes lower extremities electrical stimulation [ Time Frame: before applying electrical stimulation (baseline), immediately after 30 minutes and 60 minutes application ]
    Tissue Oxygenation will be assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)

  6. Change in physiological stress response [ Time Frame: baseline to 4 weeks ]
    Physiological stress response will be assessed by quantifying heart rate variability and using a chest-worn sensor


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent
  • 18-85 years old
  • Clinically confirmed diabetes (ADA criteria)
  • Clinically confirmed Peripheral Neuropathy
  • One or more active non-infected ulcers
  • Subject or responsible caregiver is willing and to maintain the required offloading (as applicable the location of the ulcer) and applicable dressing changes and electrical stimulation application.

Exclusion Criteria:

  • Subject has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device
  • Is pregnant
  • Is nursing or actively lactating
  • Has Renal Disease
  • Active wound infection
  • Active Charcot foot
  • Non-ambulatory (unable to walk 40 feet with or without assistive device)
  • Bilateral AK/BK amputation
  • Active drug/alcohol abuse
  • Dementia or impaired cognitive function
  • Excessive lymphedema
  • Osteomyelitis and/or gangrene
  • Unable to comply with research appointments (e.g. long travel) Wide spread malignancy or systemically imumno-compromising disease
  • Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821675


Contacts
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Contact: Bijan Najafi, PhD 7137987538 bijan.najafi@bcm.edu
Contact: Ana Enriquez, BS 7137987537 ana.enriquez@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Bijan Najafi, PhD    713-798-7536    bijan.najafi@bcm.edu   
Contact: Ana Enriquez, BS    713-798-7537    ana.enriquez@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Avazzia, Inc
More Information
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Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03821675    
Other Study ID Numbers: H-44704
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
electrical stimulation
wound healing
skin perfusion
 home based therapy
diabetic foot
Foot ulcer
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Foot
Peripheral Arterial Disease
Peripheral Vascular Diseases
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
 Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Neuromuscular Diseases
Nervous System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases