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

Stopped early · Phase 1/Phase 2

Conditions studied: Non-healing Soft Tissue Wounds

In brief

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.

Key facts

Study ID

NCT01784887

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

2

Starts

2013-01-01

Expected to finish

2015-03-01

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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.

You may not qualify 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 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.

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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