Electrical Stimulation to Accelerate Wound Healing

Baylor College of Medicine

Status: Completed

Conditions: Peripheral Neuropathy; Diabetes; Peripheral Arterial Disease; Diabetic Foot Ulcer

Treatments: Device: Electrical Stimulation - Active; Device: Electrical Stimulation - Sham

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03821675

H-44704

Details and patient eligibility

About

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.

Full 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)

Enrollment: 38 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Electrical Stimulation - Active

Active Comparator group

Description:

Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.

Treatment:

Device: Electrical Stimulation - Active

Electrical Stimulation - Sham

Sham Comparator group

Description:

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.

Treatment:

Device: Electrical Stimulation - Sham