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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
38
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Baylor College of Medicine
Houston, Texas, United States
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.
Time frame: 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.
Time frame: Change at 4 weeks from baseline
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.
Time frame: 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.
Time frame: 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)
Time frame: Change at 4 weeks from baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.