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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Peripheral Arterial Disease; Diabetic Foot Ulcer; Peripheral Neuropathy
• Intervention / Treatment: Device: Electrical Stimulation - Active; Device: Electrical Stimulation - Sham

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)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Skin Perfusion in Response to Electrical Stimulation	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.	an average of 60 minutes from baseline

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Avazzia, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: electrical stimulation; wound healing; diabetic foot; skin perfusion; Foot ulcer; home based therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Neuromuscular Diseases; Atherosclerosis; Diabetic Foot; Foot Ulcer; Ulcer; Peripheral Arterial Disease; Peripheral Vascular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: H-44704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No