Exciflex for Chronic Wound Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exciflex.
- Who it may be relevant to
- Registry conditions: Chronic Wound, Diabetes, Spinal Cord Injury, Ischemic Wound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds
Overview
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 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. 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.
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. Group A will include eight (8) participants using the study device. Group B will include eight (8) participants undergoing standard of care treatment (SoC) with no study device.
Interventions
- Device exciflex
untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.
Primary outcome measures
- Digital imaging [Time frame: At each bandage change for up to 6 weeks]
- IR imaging [Time frame: At each bandage change for up to 6 weeks]
- Laser Speckle imaging [Time frame: At each bandage change for up to 6 weeks]
Secondary outcome measures (1)
- Wound swabs [Time frame: At every bandage change for up to 6 weeks]
Eligibility criteria
Inclusion criteria
- All participants with chronic ischemic 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
Exclusion criteria
In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
- Age less than 18 years.
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Identifiers
NCT: NCT04887688 · F2166-R