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

NCT01784887 | Terminated Phase 1 DMC

• 2 other identifiers: 370421I-11-38
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-healing Soft Tissue Wounds

Outcome Measures

Primary Outcomes (1)

• Clinical Efficacy

  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.

  2 years

Secondary Outcomes (1)

• Dressing Efficacy

  2 Years

Other Outcomes (1)

• No other outcome measures

  No other outcome measures

Study Arms (2)

Bioelectric Dressing

ACTIVE COMPARATOR

SOC + Bioelectric Dressing

Drug: Procellera

SOC

NO INTERVENTION

Standard of Care

Interventions

Procellera DRUG

PROCELLERA TM is an FDA-cleared bioelectrical dressing delivered in a sterile, single layer sheet consisting of a flexible polyester fabric layer containing silver and zinc, which are held in position on the polyester with a biocompatible binder.

Also known as: Bioelectric Dressing

Bioelectric Dressing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Blount AL, Foster S, Rapp DA, Wilcox R. The use of bioelectric dressings in skin graft harvest sites: a prospective case series. J Burn Care Res. 2012 May-Jun;33(3):354-7. doi: 10.1097/BCR.0b013e31823356e4.

  PMID: 21979844 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)