AVAZZIA Electrical Stimulation
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ClinicalTrials.gov Identifier: NCT03821675 |
Recruitment Status :
Recruiting
First Posted : January 30, 2019
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Diabetic Foot Ulcer Peripheral Neuropathy Peripheral Arterial Disease | Device: Electrical Stimulation Device: Electrical Stimulation - Sham | Phase 2 Phase 3 |
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 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, 2021 |
Estimated Study Completion Date : | December 15, 2021 |

Arm | Intervention/treatment |
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Active Comparator: Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
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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.
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Device: Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
- 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)
- 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.
- 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.
- 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)
- 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
- Change in wound size from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]wound size will be quantified using wound imaging systems
- change in plantar sensation from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]plantar sensation will be quantified using a neurothesiometer
- 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)
- 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)
- 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)
- 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)
- 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

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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 |
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.

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
Contact: Bijan Najafi, PhD | 7137987538 | bijan.najafi@bcm.edu | |
Contact: Ana Enriquez, BS | 7137987537 | ana.enriquez@bcm.edu |
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 |
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: | November 12, 2020 |
Last Verified: | November 2020 |
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 |
electrical stimulation wound healing skin perfusion |
home based therapy diabetic foot Foot ulcer |
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 |