Electrical Stimulation to Accelerate Wound Healing

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03821675
• Collaborator: Avazzia, Inc (Industry)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetic Foot Ulcer; Peripheral Neuropathy; Peripheral Arterial Disease	Device: Electrical Stimulation - Active; Device: Electrical Stimulation - Sham	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Devices may be active or sham.
• Primary Purpose: Supportive Care
• Official Title: Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial
• Actual Study Start Date: Feb 28, 2019
• Actual Primary Completion Date: Mar 15, 2020
• Actual Study Completion Date: Oct 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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)

Other Outcome Measures

1. Change From Baseline in Skin Perfusion in Response to Electrical Stimulation [an average of 60 minutes 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• Avazzia, Inc

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 27, 2019
• Statistical Analysis Plan - Oct 8, 2021

More Information

Publications

None provided.

• Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03821675
• Other Study ID Numbers: H-44704
• First Posted: Jan 30, 2019
• Last Update Posted: May 9, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine: electrical stimulation; wound healing; skin perfusion; home based therapy; diabetic foot; Foot ulcer
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases; Foot Ulcer; Ulcer

Study Results

Participant Flow

Arm/Group Title	Active	Sham
Arm/Group Description	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.
Period Title: Overall Study
STARTED	19	19
COMPLETED	16	17
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Active	Sham	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	16	17	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (13.8)	61.4 (11.2)	63.2 (8.3)
Sex: Female, Male (Count of Participants)
Female	6 37.5%	6 35.3%	12 36.4%
Male	10 62.5%	11 64.7%	21 63.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 43.8%	5 29.4%	12 36.4%
White	9 56.3%	12 70.6%	21 63.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Skin Perfusion in Response to Electrical Stimulation Therapy
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Sham
Arm/Group Description	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.
Measure Participants	16	17
Mean (Standard Deviation) [mmHg]	65.1 (19.1)	72.2 (18.1)

2. Primary Outcome

Title	Change in Wound Size in Response to Electrical Stimulation Therapy
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Sham
Arm/Group Description	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.
Measure Participants	16	17
Mean (Standard Deviation) [cm2]	5.8 (8)	3.2 (8.7)

3. Secondary Outcome

Title	Change in Plantar Sensation in Response to Electrical Stimulation
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Sham
Arm/Group Description	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.
Measure Participants	16	17
Mean (Standard Deviation) [Volts]	20.2 (14)	32.1 (9.2)

4. Secondary Outcome

Title	Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation
Description	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.

Outcome Measure Data

Analysis Population Description

Active electrical stimulation was performed during one hour on all participants before randomization.

Arm/Group Title	Active	Sham
Arm/Group Description	Subjects will receive an active electrical stimulation device to wear for 1 hour	Subjects did not receive sham device for this outcome measure.
Measure Participants	38	0
Mean (Standard Deviation) [SatO2%]	73.5 (12.5)

5. Secondary Outcome

Title	Change in Tissue Oxygen Saturation in Response to Electrical Stimulation
Description	Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)
Time Frame	Change at 4 weeks from baseline.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Sham
Arm/Group Description	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.
Measure Participants	16	17
Mean (Standard Deviation) [SatO2%]	72.3 (21.5)	73.9 (12.1)

6. Other Pre-specified Outcome

Title	Change From Baseline in Skin Perfusion in Response to Electrical Stimulation
Description	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	an average of 60 minutes from baseline

Outcome Measure Data

Analysis Population Description

Active electrical stimulation was performed during one hour on all participants before randomization.

Arm/Group Title	Active	Sham
Arm/Group Description	Subjects will receive an active electrical stimulation device to wear for 1 hour	Subjects did not receive sham device for this outcome measure.
Measure Participants	38	0
Mean (Standard Deviation) [mmHg]	79.9 (18.3)

Adverse Events

Time Frame	an average of 4 weeks from baseline.
Adverse Event Reporting Description	0
Arm/Group Title	Active		Sham
Arm/Group Description	intervention		control
All Cause Mortality
	Active		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Serious Adverse Events
	Active		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Active		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.