N/A
Completed N=38
Electrical Stimulation to Accelerate Wound Healing
Source: ClinicalTrials.gov NCT03821675 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Change in Skin Perfusion in Response to Electrical Stimulation Therapy — 65.1; 72.2 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Skin Perfusion in Response to Electrical Stimulation Therapy |
65.1; 72.2 | — |
| PRIMARY Change in Wound Size in Response to Electrical Stimulation Therapy |
5.8; 3.2 | — |
| SECONDARY Change in Plantar Sensation in Response to Electrical Stimulation |
20.2; 32.1 | — |
| SECONDARY Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation |
73.5 | — |
| SECONDARY Change in Tissue Oxygen Saturation in Response to Electrical Stimulation |
72.3; 73.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03821675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.