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| Name | Class |
|---|---|
| Avazzia, Inc | INDUSTRY |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation - Active | Active Comparator | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. |
|
| Electrical Stimulation - Sham | Sham Comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation - Active | Device | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change at 4 weeks from baseline. |
| 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. | Change at 4 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change at 4 weeks from baseline. |
| Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | an average of 60 minutes from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. |
| FG001 | Sham | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. |
| BG001 | Sham | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmHg | Change at 4 weeks from baseline. |
|
an average of 4 weeks from baseline.
0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Bijan Najafi | Baylor College of Medicine | 17137987536 | bijan.najafi@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2019 | Feb 2, 2022 | Prot_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2021 | Nov 11, 2021 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| D010523 | Peripheral Nervous System Diseases |
| D058729 | Peripheral Arterial Disease |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Devices may be active or sham.
| Electrical Stimulation - Sham | Device | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
|
Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline. |
| Change at 60 minutes from baseline. |
| Change in Tissue Oxygen Saturation in Response to Electrical Stimulation | Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) | Change at 4 weeks from baseline. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | cm2 | Change at 4 weeks from baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Volts | Change at 4 weeks from baseline. |
|
|
|
| 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. | Active electrical stimulation was performed during one hour on all participants before randomization. | Posted | Mean | Standard Deviation | SatO2% | Change at 60 minutes from baseline. |
|
|
|
| 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) | Posted | Mean | Standard Deviation | SatO2% | Change at 4 weeks from baseline. |
|
|
|
| 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. | Active electrical stimulation was performed during one hour on all participants before randomization. | Posted | Mean | Standard Deviation | mmHg | an average of 60 minutes from baseline |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham | control | 0 | 17 | 0 | 17 | 0 | 17 |
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| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D005534 | Foot Diseases |