Diabetes, Diabetic Foot Ulcer, Peripheral Arterial Disease, Peripheral Neuropathy
Conditions
Keywords
electrical stimulation, wound healing, skin perfusion, home based therapy, diabetic foot, Foot ulcer
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)
Interventions
DEVICEElectrical Stimulation - Active
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
Sponsors
Avazzia, Inc
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Devices may be active or sham.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Perfusion in Response to Electrical Stimulation Therapy | 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. |
| Change in Wound Size in Response to Electrical Stimulation Therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Plantar Sensation in Response to Electrical Stimulation | Change at 4 weeks from baseline. | change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel. |
| Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation | 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. |
| Change in Tissue Oxygen Saturation in Response to Electrical Stimulation | Change at 4 weeks from baseline. | Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Skin Perfusion in Response to Electrical Stimulation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. | 16 |
| Sham Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Sham | Total | Active |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 11.2 | 63.2 years STANDARD_DEVIATION 8.3 | 65.1 years STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 21 Participants | 9 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Change in Skin Perfusion in Response to Electrical Stimulation Therapy
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.
Time frame: Change at 4 weeks from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Skin Perfusion in Response to Electrical Stimulation Therapy | 65.1 mmHg | Standard Deviation 19.1 |
| Sham | Change in Skin Perfusion in Response to Electrical Stimulation Therapy | 72.2 mmHg | Standard Deviation 18.1 |
Primary
Change in Wound Size in Response to Electrical Stimulation Therapy
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.
Time frame: Change at 4 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Wound Size in Response to Electrical Stimulation Therapy | 5.8 cm2 | Standard Deviation 8 |
| Sham | Change in Wound Size in Response to Electrical Stimulation Therapy | 3.2 cm2 | Standard Deviation 8.7 |
Secondary
Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation
Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.
Time frame: Change at 60 minutes from baseline.
Population: Active electrical stimulation was performed during one hour on all participants before randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation | 73.5 SatO2% | Standard Deviation 12.5 |
Secondary
Change in Plantar Sensation in Response to Electrical Stimulation
change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.
Time frame: Change at 4 weeks from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Plantar Sensation in Response to Electrical Stimulation | 20.2 Volts | Standard Deviation 14 |
| Sham | Change in Plantar Sensation in Response to Electrical Stimulation | 32.1 Volts | Standard Deviation 9.2 |
Secondary
Change in Tissue Oxygen Saturation in Response to Electrical Stimulation
Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)
Time frame: Change at 4 weeks from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Tissue Oxygen Saturation in Response to Electrical Stimulation | 72.3 SatO2% | Standard Deviation 21.5 |
| Sham | Change in Tissue Oxygen Saturation in Response to Electrical Stimulation | 73.9 SatO2% | Standard Deviation 12.1 |
Other Pre-specified
Change From Baseline in Skin Perfusion in Response to Electrical Stimulation
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.
Time frame: an average of 60 minutes from baseline
Population: Active electrical stimulation was performed during one hour on all participants before randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline in Skin Perfusion in Response to Electrical Stimulation | 79.9 mmHg | Standard Deviation 18.3 |