Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment, quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in wound healing will be observed on a cellular, histomorphological and clinical level in the presence of a bioelectric dressing applied in conjunction with SOC.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Criteria

Inclusion 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 external wound at any location of the body of ≥90 days duration that is (10-50 cm2) at initial screening and does not exceed 3 cm in depth.

• May have a wound requiring Negative Pressure Wound Therapy in conjunction with standard of care wound treatment.

• 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)47-49 of >30mmHg recorded over intact epidermis near the open wound margin.

• Subjects with arterial repairs having 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:

• 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 based upon previous imaging or historical information from the subject's chart.

• 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.