DiabetesNCT03821675
Electrical Stimulation to Accelerate Wound Healing
A study testing Electrical Stimulation - Active in people with Diabetes and Diabetic Foot Ulcer, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy
- What is being tested?
- Electrical Stimulation - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial
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.
Read the 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)
- Being tested
- Electrical Stimulation - Active, Electrical Stimulation - Sham
- Keywords
- electrical stimulation, wound healing, skin perfusion, home based therapy, diabetic foot, Foot ulcer
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Peripheral Nervous System Diseases, Peripheral Arterial Disease, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation - ActiveDevice
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
Electrical Stimulation - ShamDevice
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation - Active | Active comparator | Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. Receives: Device: Electrical Stimulation - Active |
| Electrical Stimulation - Sham | Sham comparator | Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. Receives: Device: Electrical Stimulation - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change at 4 weeks from baseline
Secondary outcomes (3)
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.
Measured: Change at 4 weeks from baseline.
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.
Measured: 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)
Measured: Change at 4 weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start28 Feb 2019
- Primary completion15 Mar 2020
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Avazzia, Inc
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821675
- Sponsor's protocol ID
- H-44704
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2019
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03821675
- Acronym / sponsor ID
- H-44704
- Keywords
- electrical stimulation, wound healing, skin perfusion, home based therapy, diabetic foot, Foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Avazzia, Inc
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation - Active | Active comparator | Device: Electrical Stimulation - ActiveSubjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. |
| Electrical Stimulation - Sham | Sham comparator | Device: Electrical Stimulation - ShamSubjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Stimulation - ActiveSubjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks. | Device | Electrical Stimulation - Active |
| Electrical Stimulation - ShamSubjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks. | Device | Electrical Stimulation - Sham |
Primary outcome
Change in Skin Perfusion in Response to Electrical Stimulation Therapy
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Plantar Sensation in Response to Electrical Stimulation
Time frame: Change at 4 weeks from baseline.
Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation
Time frame: Change at 60 minutes from baseline.
Change in Tissue Oxygen Saturation in Response to Electrical Stimulation
Time frame: Change at 4 weeks from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation - Active in people with Diabetes and Diabetic Foot Ulcer, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Perfusion in Response to Electrical Stimulation Therapy (time frame: Change at 4 weeks from baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.