Clinical trial NCT03821675: Electrical Stimulation to Accelerate Wound Healing
Official title: Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetic Foot Ulcer
Peripheral Neuropathy
Peripheral Arterial Disease
Keywords: electrical stimulation
wound healing
skin perfusion
home based therapy
diabetic foot
Foot ulcer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Avazzia, Inc
First posted: 2019-01-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Skin Perfusion in Response to Electrical Stimulation Therapy
timeFrame: Change at 4 weeks from baseline.
measure: Change in Wound Size in Response to Electrical Stimulation Therapy
timeFrame: Change at 4 weeks from baseline
Secondary outcomes:
measure: Change in Plantar Sensation in Response to Electrical Stimulation
timeFrame: Change at 4 weeks from baseline.
measure: Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation
timeFrame: Change at 60 minutes from baseline.
measure: Change in Tissue Oxygen Saturation in Response to Electrical Stimulation
timeFrame: Change at 4 weeks from baseline.
Other outcomes:
measure: Change From Baseline in Skin Perfusion in Response to Electrical Stimulation
timeFrame: an average of 60 minutes from baseline
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: