Status:
COMPLETED
Electrical Stimulation to Accelerate Wound Healing
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Avazzia, Inc
Conditions:
Diabetes
Diabetic Foot Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 T...
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 stimul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03821675
Start Date
February 28 2019
End Date
October 8 2021
Last Update
May 9 2022
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030