Trials: Clinical and mechanistic demonstration of a Bioelectric Dressing System for non-healing wound management: A Phase II randomized trial $\/$

Primary and Secondary Objectives

Primary Objective:

Assessment of the clinical efficacy of a bioelectric dressing in conjunction with standard-of-care on the healing rate of chronic soft tissue wounds compared with standard-of-care alone. In this 50-subject study, the primary endpoint for efficacy will be the rate of healing (healing trajectory) in the treatment group compared to that of the control group, during the 12-week treatment study period. It is hypothesized that a bioelectric dressing will reduce wound healing time when compared to SOC treatment, thereby accelerating wound healing trajectory.

Secondary Objective:

To demonstrate the efficacy of a bioelectric dressing in the areas of enhanced and accelerated wound healing on a clinical, histomorphological and cellular level studied through wound healing with decreased incidence of bacterial infection, decreased pain levels for chronic non healing wounds studied through standard validated pain assessment tools, and improved quality of life (QOL), using complex non-healing wounds as a model for tissue response. Secondary endpoints for efficacy will be study wound inflammatory infiltrate, bacterial load, and patient reported pain and quality of life (QOL) by means of visual acuity score (VAS) and SF-12, respectively.

Inclusion and Exclusion Criteria

Inclusion Criteria:

Subjects eligible for enrollment in the study must meet all of the following criteria:

18 years of age or older, male or female
Female subject not pregnant - pregnancy excluded by HCG (urine or serum) or by history (tubal ligation, hysterectomy, or menopause).
Have a non-healing wound of ³90 days duration that is (10-50 cm²)at initial screening and does not exceed 3 cm in depth.
Subject is able to apply study dressing to his/her wound, or have a reliable and capable caregiver to do it.
Subjects will have adequate blood flow to the wound as defined by Skin Perfusion Pressure (SPP) of >30mmHg recorded over intact epidermis near the open wound margin.
Absence of clinical signs of infection (such as fever; malodorous wound exudate; increasing wound pain, drainage, erythema, friable granulation tissue and or edema).
Participant agrees to participate in follow-up evaluations.
Participant must be able to read and understand informed consent, and signs the informed consent.

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study if:

Less than 18 years of age.
Pregnant or lactating woman.
Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months.
Currently undergoing dialysis for renal failure.
Subject has wounds resulting from electrical burn, arterial insufficiency, chemical or radiation insult.
Subject has wounds with exposed bone, ligament, nerve, artery and/or tendon.
Active or previous (within 60 days prior to the study screening visit) chemotherapy.
Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by study device or standard of care.
Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits.
The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including application of bioelectric dressings, standard-of-care self-care requirements, and all study-related follow up visit requirements.
History of infection with Human Immunodeficiency Virus or other immunodeficiency disorders.
Heterotopic ossification underlying the wound.
Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females) or coagulopathy (INR > 1.7).
Severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 6 weeks).
Allergy to silver or zinc.

Participating Site

Walter Reed National Military Medical Center

Contact: COL Alexander Stojadinovic MD, Principal Investigator, alexander.stojadinovic@med.navy.mil

Sponsor: Dressing - Vomaris, Inc. http://www.vomaris.com Funding – Air Force Medical Service

Trials: Clinical and mechanistic demonstration of a Bioelectric Dressing System for non-healing wound management: A Phase II randomized trial