Chronic WoundNCT04887688
Exciflex Electroceutical Banadage for Chronic Wound Therapy
A study testing exciflex in people with Chronic Wound and Diabetes, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound, Diabetes, Spinal Cord Injury
- What is being tested?
- exciflex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants with chronic wounds treated at LSCVAMC will be potentially eligible for the study
- Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care
Who cannot join
- In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Katie R Schwartz, RN, (216) 791-3800 ext. 63802, Katelyn.Schwartz@va.gov
Kath M. Bogie, PhD
About this study
Official title: Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.
Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.
Read more
Methodology: All participants with chronic ischemic wounds treated at Louis Stokes Cleveland VA Medical Center (LSCDVAMC) will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1) Age less than 18 years and (2) Pregnancy.
Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.
Read the detailed description
The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Non-invasive assessments will include multi-modal imaging using the Mimosa Pro imaging system, MolecuLight and wound swabs to collect wound bed fluid thus meeting the recommendations of Ramsay et al. for obtaining accurate, reliable standardized samples. Wound healing primary endpoints will follow Wound Care Collaborative Community guidance. The study cohort will comprise Veterans with chronic wounds.
A parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. The two groups are Group A (exciflex treatment and monitoring) or Group B (sham treatment, i.e. exciflex monitoring without treatment activated)
- Conditions
- Chronic Wound, Diabetes, Spinal Cord Injury, Ischemic Wound
- Being tested
- exciflex
- Medical subject headings
- Diabetes Mellitus, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exciflexDevice
untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Wound treated using exciflex | Experimental | Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound. Receives: Device: exciflex |
| Group B: Wound treated using standard of care | No intervention | Control treated wounds in Group B participants will be covered with an exciflex bandage that is not activated . The bandage will be used for up to 10 weeks or until the wound is healed for 3 days. The bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs . A fresh sterile inactive exciflex bandage will then be reapplied to the wound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital imaging
Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area \& wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) \& wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.
Measured: At each bandage change for up to 6 weeks
IR imaging
Wound bed temperature (degrees C)
Measured: At each bandage change for up to 6 weeks
Laser Speckle imaging
Wound region blood flow (blood perfusion using arbitrary units)
Measured: At each bandage change for up to 6 weeks
Secondary outcomes (1)
Wound swabs
Further analysis using real-time polymerase chain reaction (PCR) for assessment of wound infection and healing biomarkers, including but not limited to VEGF and TNF-alpha. rt-PCR is a single assessment process to measure multiple biomarkers of wound infection and healing from a single sample, using plates that contain up to 96 different biomarkers each.
Measured: At every bandage change for up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start5 Oct 2022
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the baseline assessment, the wound dressing will be removed and wound status will be evaluated. Participants will then be randomly assigned to the intervention group (Group A) or control group (Group B). Progressive changes in wound size, indicative of wound healing, will be determined using 3D digital stereophotogrammetry (LifeViz 3D system, Quantificare Inc., San Mateo, CA) together with wound swabs to collect wound bed fluid. The study cohort will comprise Veterans with ischemic wounds.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kath M. Bogie, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887688
- Sponsor's protocol ID
- F2166-R
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2021
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds
- ClinicalTrials.gov ID
- NCT04887688
- Acronym / sponsor ID
- F2166-R
- Conditions
- Chronic Wound, Diabetes, Spinal Cord Injury, Ischemic Wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.
Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.
Methodology: All participants with chronic ischemic wounds treated at Louis Stokes Cleveland VA Medical Center (LSCDVAMC) will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1) Age less than 18 years and (2) Pregnancy.
Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.
Detailed description
The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Non-invasive assessments will include multi-modal imaging using the Mimosa Pro imaging system, MolecuLight and wound swabs to collect wound bed fluid thus meeting the recommendations of Ramsay et al. for obtaining accurate, reliable standardized samples. Wound healing primary endpoints will follow Wound Care Collaborative Community guidance. The study cohort will comprise Veterans with chronic wounds.
A parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. The two groups are Group A (exciflex treatment and monitoring) or Group B (sham treatment, i.e. exciflex monitoring without treatment activated)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At the baseline assessment, the wound dressing will be removed and wound status will be evaluated. Participants will then be randomly assigned to the intervention group (Group A) or control group (Group B). Progressive changes in wound size, indicative of wound healing, will be determined using 3D digital stereophotogrammetry (LifeViz 3D system, Quantificare Inc., San Mateo, CA) together with wound swabs to collect wound bed fluid. The study cohort will comprise Veterans with ischemic wounds.
| Arm | Type | Receives |
|---|---|---|
| Group A: Wound treated using exciflex | Experimental | Device: exciflexIntervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound. |
| Group B: Wound treated using standard of care | No intervention | –Control treated wounds in Group B participants will be covered with an exciflex bandage that is not activated . The bandage will be used for up to 10 weeks or until the wound is healed for 3 days. The bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs . A fresh sterile inactive exciflex bandage will then be reapplied to the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants with chronic wounds treated at LSCVAMC will be potentially eligible for the study
- Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care
Key exclusion criteria (2 listed)
- In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
- Pregnancy
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 |
|---|---|---|
| exciflexuntethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate. | Device | Group A: Wound treated using exciflex |
Primary outcome
Digital imaging
Time frame: At each bandage change for up to 6 weeks
Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area \& wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) \& wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.
IR imaging
Time frame: At each bandage change for up to 6 weeks
Wound bed temperature (degrees C)
Laser Speckle imaging
Time frame: At each bandage change for up to 6 weeks
Wound region blood flow (blood perfusion using arbitrary units)
1 secondary outcome
Wound swabs
Time frame: At every bandage change for up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- 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.
Kath M. Bogie, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exciflex in people with Chronic Wound and Diabetes, run by VA Office of Research and Development 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kath M Bogie, PhD ((204) 778-3083, Katherine.Bogie@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital imaging (time frame: At each bandage change for up to 6 weeks). The study lists 3 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 10 Aug 2026.