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Completed

NCT Number: NCT03821675

Electrical Stimulation to Accelerate Wound Healing

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrical Stimulation - Active

Device

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

Electrical Stimulation - Sham

Device

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

Primary outcomes

  1. Change in Skin Perfusion in Response to Electrical Stimulation Therapy

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Plantar Sensation in Response to Electrical Stimulation

    Time frame: 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

    Time frame: 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

    Time frame: Change at 4 weeks from baseline.

    Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)

Other outcomes

  1. Change From Baseline in Skin Perfusion in Response to Electrical Stimulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Avazzia, Inc

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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