AVAZZIA Electrical Stimulation
AVAZZIA Electrical Stimulation
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.
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)
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.