Electrical Stimulation to Accelerate Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial

Conditions
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Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy, Peripheral Arterial Disease

Intervention / Treatment
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* Device: Electrical Stimulation - Active
* Device: Electrical Stimulation - Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electrical Stimulation - Active<br>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. | Device: Electrical Stimulation - Active<br>* Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.<br>|
| Sham Comparator: Electrical Stimulation - Sham<br>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. | Device: Electrical Stimulation - Sham<br>* Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Perfusion in Response to Electrical Stimulation Therapy | Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors. | Change at 4 weeks from baseline. | 
| Change in Wound Size in Response to Electrical Stimulation Therapy | Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area. | Change at 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plantar Sensation in Response to Electrical Stimulation | change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel. | Change at 4 weeks from baseline. | 
| Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation | Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline. | Change at 60 minutes from baseline. | 
| Change in Tissue Oxygen Saturation in Response to Electrical Stimulation | Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) | Change at 4 weeks from baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, wound healing, skin perfusion, home based therapy, diabetic foot, Foot ulcer