A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.
Primary Purpose
Chronic Wounds
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atteris Antimicrobial Skin and Wound Cleanser
Atteris Antimicrobial Barrier Film Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wounds
Eligibility Criteria
Inclusion Criteria:
- Male or female between the ages of 18 and 89
- If IDDM or NIDDM, glycosylated hemoglobin, HgbA1c, ≤10%
- Presence of chronic Wound of any etiology between 0.5 cm2 and 15 cm2, inclusive, post debridement
- Wound has been present for at least 4 weeks, but not greater than 52 weeks at time of screening
- Non-surgical wounds which meet the clinical definition of chronic between 0.5 cm2 and 15 cm2
Adequate arterial perfusion of the affected limb, defined as at least one of the following:
- Ankle-brachial index (ABI) ≥0.7 and ≤1.2
- Dorsum transcutaneous oxygen test ≥ 30 mm Hg
- Biphasic or triphasic Doppler waveforms at screening
- Patient and/or caregiver have the ability and willingness to understand and comply with study procedures and give written, informed consent prior to enrollment in the study or initiation of study procedures.
Exclusion Criteria:
- Suspected or confirmed signs/symptoms of active wound infection or gangrene
- Hyperbaric Oxygen Therapy, any duration, within the past 12 months
- Osteomyelitis
- Use of oral or IV antibiotic/antimicrobial agents within 2 days (48 hours) of baseline
- Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin,) within 28 days of screening
- Subjects who have received dermal substitutes (e.g. Integra, collagen, micronized cadaver skin, bilayered cell therapy, dermal substitute, extracellular matrix etc.) within 28 days of screening.
- Pyoderma gangrenosum, or Reynaud's disease
- Wound with necrotic tissue covered with slough or eschar that cannot be debrided
- Chronic wounds with exposed bone
- Wounds with fistulas or deep sinus tracks of unknown depth
- Active Charcot foot on the study limb
- Receiving hemodialysis or peritoneal dialysis
- History of malignancy excluding non-melanoma skin cancer
- Treatment with radiation or chemotherapy within 3 months of screening
- Known immunosuppression, excluding diabetes mellitus
- Receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to affect wound healing, such as systemic steroids (such as daily prednisone), immunosuppressive therapy, radiation or chemotherapy of any kind, autoimmune disease therapy or cytostatic therapy
- Subjects with known alcohol or substance abuse within 6 months of screening
- Subjects with known allergy to PHMB, acrylate polymer and silicone
- Pregnancy or breastfeeding at time of screening
- Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening
Sites / Locations
- AZH Wound & Hyperbaric Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Active AWC + Active ABFD
Active AWC + Placebo ABFD
Placebo AWC + Active ABFD
Placebo AWC + Placebo ABFD
Arm Description
Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Outcomes
Primary Outcome Measures
Complete Closure
Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)
Secondary Outcome Measures
Infective episodes
The number of infective episodes for which oral or IV antibiotics are prescribed
Pain
Pain as reported using a Wong Baker Scale
Wound Dimension Decreases
The percentage change in wound size relative to the baseline measurement
Full Information
NCT ID
NCT03198169
First Posted
June 22, 2017
Last Updated
April 4, 2018
Sponsor
Atteris Healthcare, LLC
Collaborators
Rochal Industries LLC
1. Study Identification
Unique Protocol Identification Number
NCT03198169
Brief Title
A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.
Official Title
2-part, Randomized, Double Blind, Prospective, Single Center, Controlled Trial to Investigate an Antimicrobial Skin and Wound Cleanser and an Antimicrobial Barrier Film Dressing on the Rates of Healing for Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Inconsistent results in pilot phase
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atteris Healthcare, LLC
Collaborators
Rochal Industries LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.
Detailed Description
Part 1 of this study will involve 5 patients with qualified chronic wounds which will receive active treatment with both the Atteris Antimicrobial Skin and Wound Cleanser (AWC) and the Atteris Antimicrobial Barrier Film Dressing (ABFD) for a 6-week period with a 12 week follow-up in order to optimize the final study application protocols. Part 2 of this study is a randomized, double blind, 2 by 2 factorial, controlled study comparing the AWC and/or the ABFD with 100 research subjects and n=25 subjects per cell. Patients will be randomized to receive either active AWC and active ABFD, or active AWD and placebo ABFD, or placebo AWC and active ABFC, or AWC placebo and ABFD placebo in addition to standard of care (SOC). The active AWC active ABFD versus AWC placebo ABFD placebo statistical contrast will be of most importance and the clinical expectation is wounds treated with the active forms of these products will heal faster than wounds treated with double placebo and this will additionally provide data to power a future definitive study to compare the healing potential of the two therapeutic modalities (AWC, ABFD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Active product containers and placebo product containers will have identical labels. Product numbers to differentiate active versus placebo will be assigned and known only by the statistician.
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active AWC + Active ABFD
Arm Type
Experimental
Arm Description
Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Arm Title
Active AWC + Placebo ABFD
Arm Type
Experimental
Arm Description
Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Arm Title
Placebo AWC + Active ABFD
Arm Type
Experimental
Arm Description
Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Arm Title
Placebo AWC + Placebo ABFD
Arm Type
Experimental
Arm Description
Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Intervention Type
Device
Intervention Name(s)
Atteris Antimicrobial Skin and Wound Cleanser
Intervention Description
Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.
Intervention Type
Device
Intervention Name(s)
Atteris Antimicrobial Barrier Film Dressing
Intervention Description
Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.
Primary Outcome Measure Information:
Title
Complete Closure
Description
Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)
Time Frame
6 weeks of active treatment
Secondary Outcome Measure Information:
Title
Infective episodes
Description
The number of infective episodes for which oral or IV antibiotics are prescribed
Time Frame
6 weeks
Title
Pain
Description
Pain as reported using a Wong Baker Scale
Time Frame
6 weeks
Title
Wound Dimension Decreases
Description
The percentage change in wound size relative to the baseline measurement
Time Frame
6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between the ages of 18 and 89
If IDDM or NIDDM, glycosylated hemoglobin, HgbA1c, ≤10%
Presence of chronic Wound of any etiology between 0.5 cm2 and 15 cm2, inclusive, post debridement
Wound has been present for at least 4 weeks, but not greater than 52 weeks at time of screening
Non-surgical wounds which meet the clinical definition of chronic between 0.5 cm2 and 15 cm2
Adequate arterial perfusion of the affected limb, defined as at least one of the following:
Ankle-brachial index (ABI) ≥0.7 and ≤1.2
Dorsum transcutaneous oxygen test ≥ 30 mm Hg
Biphasic or triphasic Doppler waveforms at screening
Patient and/or caregiver have the ability and willingness to understand and comply with study procedures and give written, informed consent prior to enrollment in the study or initiation of study procedures.
Exclusion Criteria:
Suspected or confirmed signs/symptoms of active wound infection or gangrene
Hyperbaric Oxygen Therapy, any duration, within the past 12 months
Osteomyelitis
Use of oral or IV antibiotic/antimicrobial agents within 2 days (48 hours) of baseline
Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin,) within 28 days of screening
Subjects who have received dermal substitutes (e.g. Integra, collagen, micronized cadaver skin, bilayered cell therapy, dermal substitute, extracellular matrix etc.) within 28 days of screening.
Pyoderma gangrenosum, or Reynaud's disease
Wound with necrotic tissue covered with slough or eschar that cannot be debrided
Chronic wounds with exposed bone
Wounds with fistulas or deep sinus tracks of unknown depth
Active Charcot foot on the study limb
Receiving hemodialysis or peritoneal dialysis
History of malignancy excluding non-melanoma skin cancer
Treatment with radiation or chemotherapy within 3 months of screening
Known immunosuppression, excluding diabetes mellitus
Receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to affect wound healing, such as systemic steroids (such as daily prednisone), immunosuppressive therapy, radiation or chemotherapy of any kind, autoimmune disease therapy or cytostatic therapy
Subjects with known alcohol or substance abuse within 6 months of screening
Subjects with known allergy to PHMB, acrylate polymer and silicone
Pregnancy or breastfeeding at time of screening
Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS
Organizational Affiliation
AZH Wound & Hyperbaric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZH Wound & Hyperbaric Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19903300
Citation
Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
Results Reference
background
PubMed Identifier
15147991
Citation
Gottrup F. A specialized wound-healing center concept: importance of a multidisciplinary department structure and surgical treatment facilities in the treatment of chronic wounds. Am J Surg. 2004 May;187(5A):38S-43S. doi: 10.1016/S0002-9610(03)00303-9.
Results Reference
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PubMed Identifier
19152648
Citation
Wicke C, Bachinger A, Coerper S, Beckert S, Witte MB, Konigsrainer A. Aging influences wound healing in patients with chronic lower extremity wounds treated in a specialized Wound Care Center. Wound Repair Regen. 2009 Jan-Feb;17(1):25-33. doi: 10.1111/j.1524-475X.2008.00438.x.
Results Reference
background
PubMed Identifier
23742279
Citation
Richmond NA, Maderal AD, Vivas AC. Evidence-based management of common chronic lower extremity ulcers. Dermatol Ther. 2013 May-Jun;26(3):187-96. doi: 10.1111/dth.12051.
Results Reference
background
PubMed Identifier
26339534
Citation
Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
Results Reference
background
PubMed Identifier
15021046
Citation
Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.
Results Reference
background
PubMed Identifier
18211576
Citation
Davis SC, Ricotti C, Cazzaniga A, Welsh E, Eaglstein WH, Mertz PM. Microscopic and physiologic evidence for biofilm-associated wound colonization in vivo. Wound Repair Regen. 2008 Jan-Feb;16(1):23-9. doi: 10.1111/j.1524-475X.2007.00303.x.
Results Reference
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PubMed Identifier
26340818
Citation
Game FL, Attinger C, Hartemann A, Hinchliffe RJ, Londahl M, Price PE, Jeffcoate WJ; International Working Group on the Diabetic Foot. IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:75-83. doi: 10.1002/dmrr.2700. No abstract available.
Results Reference
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Citation
Phillips, P., Wolcott, R., Fletcher, J. & Schultz, G. S. Biofilms made easy. Wounds Int. 2010 1, 1-6.
Results Reference
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PubMed Identifier
17651490
Citation
Herber OR, Schnepp W, Rieger MA. A systematic review on the impact of leg ulceration on patients' quality of life. Health Qual Life Outcomes. 2007 Jul 25;5:44. doi: 10.1186/1477-7525-5-44.
Results Reference
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PubMed Identifier
28654304
Citation
Niederauer MQ, Michalek JE, Armstrong DG. A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers. J Diabetes Sci Technol. 2017 Sep;11(5):883-891. doi: 10.1177/1932296817695574. Epub 2017 Feb 15.
Results Reference
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A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.
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