Study Results
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View full resultsBasic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2019-02-28
2021-10-08
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Electrical Stimulation - Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Interventions
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Electrical Stimulation - Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Avazzia, Inc
INDUSTRY
Baylor College of Medicine
OTHER
Responsible Party
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Bijan Najafi, PhD
Professor of Surgery
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H-44704
Identifier Type: -
Identifier Source: org_study_id
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