Electrical Stimulation to Accelerate Wound Healing

NCT03821675 | Completed Results DMC FDA Device

• 1 other identifier: H-44704
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

electrical stimulation; wound healing; skin perfusion; home based therapy; diabetic foot; Foot ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Plantar Sensation in Response to Electrical Stimulation

  Change at 4 weeks from baseline.

• Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation

  Change at 60 minutes from baseline.

• Change in Tissue Oxygen Saturation in Response to Electrical Stimulation

  Change at 4 weeks from baseline.

Other Outcomes (1)

• Change From Baseline in Skin Perfusion in Response to Electrical Stimulation

  an average of 60 minutes from baseline

Study Arms (2)

Electrical Stimulation - Active

ACTIVE COMPARATOR

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

Device: Electrical Stimulation - Active

Electrical Stimulation - Sham

SHAM COMPARATOR

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

Device: Electrical Stimulation - Sham

Interventions

Electrical Stimulation - Active DEVICE

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

Electrical Stimulation - Active

Electrical Stimulation - Sham DEVICE

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

Electrical Stimulation - Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Avazzia, Inc: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Peripheral Nervous System Diseases; Peripheral Arterial Disease; Foot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Foot Diseases

Results Point of Contact

• Title: Prof. Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

17137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Devices may be active or sham.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 30, 2019
• Study Start: February 28, 2019
• Primary Completion: March 15, 2020
• Study Completion: October 8, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)