Electrical Stimulation to Accelerate Wound Healing

Not Applicable

Completed

Conditions: Peripheral Neuropathy
Diabetes
Peripheral Arterial Disease
Diabetic Foot Ulcer

Interventions: Device: Electrical Stimulation - Active
Device: Electrical Stimulation - Sham

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.

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)

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation - Active	Electrical Stimulation - Active	Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - Sham	Electrical Stimulation - Sham	Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Skin Perfusion in Response to Electrical Stimulation Therapy	Change at 4 weeks from baseline.	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 in Wound Size in Response to Electrical Stimulation Therapy	Change at 4 weeks from baseline	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.

Secondary Outcome Measures

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