Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial
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|ClinicalTrials.gov Identifier: NCT01784887|
Recruitment Status : Terminated (Did not have study population to continue)
First Posted : February 6, 2013
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-healing Soft Tissue Wounds||Drug: Procellera||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Randomized Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: Bioelectric Dressing
SOC + Bioelectric Dressing
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.
Other Name: Bioelectric Dressing
No Intervention: SOC
Standard of Care
- Clinical Efficacy [ Time Frame: 2 years ]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.
- Dressing Efficacy [ Time Frame: 2 Years ]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.
- No other outcome measures [ Time Frame: No other outcome measures ]No other outcome measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784887
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|