NCT03821675

Electrical Stimulation to Accelerate Wound Healing

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diabetes
• Diabetic Foot Ulcer
• Peripheral Neuropathy
• Peripheral Arterial Disease

Interventions

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

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-03-15
• Completion: 2021-10-08
• First posted: 2019-01-30
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study