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A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.

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ClinicalTrials.gov Identifier: NCT03198169
Recruitment Status : Terminated (Inconsistent results in pilot phase)
First Posted : June 26, 2017
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Rochal Industries LLC
Information provided by (Responsible Party):
Atteris Healthcare, LLC

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.

Condition or disease Intervention/treatment Phase
Chronic Wounds Device: Atteris Antimicrobial Skin and Wound Cleanser Device: Atteris Antimicrobial Barrier Film Dressing Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active AWC + Active ABFD
Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Device: Atteris Antimicrobial Skin and Wound Cleanser
Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

Device: Atteris Antimicrobial Barrier Film Dressing
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.

Experimental: Active AWC + Placebo ABFD
Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Device: Atteris Antimicrobial Skin and Wound Cleanser
Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

Device: Atteris Antimicrobial Barrier Film Dressing
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.

Experimental: Placebo AWC + Active ABFD
Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
Device: Atteris Antimicrobial Skin and Wound Cleanser
Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

Device: Atteris Antimicrobial Barrier Film Dressing
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.

Experimental: Placebo AWC + Placebo ABFD
Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
Device: Atteris Antimicrobial Skin and Wound Cleanser
Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

Device: Atteris Antimicrobial Barrier Film Dressing
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 Measures :
  1. Complete Closure [ Time Frame: 6 weeks of active treatment ]
    Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)


Secondary Outcome Measures :
  1. Infective episodes [ Time Frame: 6 weeks ]
    The number of infective episodes for which oral or IV antibiotics are prescribed

  2. Pain [ Time Frame: 6 weeks ]
    Pain as reported using a Wong Baker Scale

  3. Wound Dimension Decreases [ Time Frame: 6 and 12 weeks ]
    The percentage change in wound size relative to the baseline measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between the ages of 18 and 89
  2. If IDDM or NIDDM, glycosylated hemoglobin, HgbA1c, ≤10%
  3. Presence of chronic Wound of any etiology between 0.5 cm2 and 15 cm2, inclusive, post debridement
  4. Wound has been present for at least 4 weeks, but not greater than 52 weeks at time of screening
  5. Non-surgical wounds which meet the clinical definition of chronic between 0.5 cm2 and 15 cm2
  6. Adequate arterial perfusion of the affected limb, defined as at least one of the following:

    1. Ankle-brachial index (ABI) ≥0.7 and ≤1.2
    2. Dorsum transcutaneous oxygen test ≥ 30 mm Hg
    3. Biphasic or triphasic Doppler waveforms at screening
  7. 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:

  1. Suspected or confirmed signs/symptoms of active wound infection or gangrene
  2. Hyperbaric Oxygen Therapy, any duration, within the past 12 months
  3. Osteomyelitis
  4. Use of oral or IV antibiotic/antimicrobial agents within 2 days (48 hours) of baseline
  5. Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin,) within 28 days of screening
  6. 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.
  7. Pyoderma gangrenosum, or Reynaud's disease
  8. Wound with necrotic tissue covered with slough or eschar that cannot be debrided
  9. Chronic wounds with exposed bone
  10. Wounds with fistulas or deep sinus tracks of unknown depth
  11. Active Charcot foot on the study limb
  12. Receiving hemodialysis or peritoneal dialysis
  13. History of malignancy excluding non-melanoma skin cancer
  14. Treatment with radiation or chemotherapy within 3 months of screening
  15. Known immunosuppression, excluding diabetes mellitus
  16. 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
  17. Subjects with known alcohol or substance abuse within 6 months of screening
  18. Subjects with known allergy to PHMB, acrylate polymer and silicone
  19. Pregnancy or breastfeeding at time of screening
  20. Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening

Information from the National Library of Medicine

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): NCT03198169


Locations
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United States, Wisconsin
AZH Wound & Hyperbaric Center
Milwaukee, Wisconsin, United States, 53221
Sponsors and Collaborators
Atteris Healthcare, LLC
Rochal Industries LLC
Investigators
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Principal Investigator: Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS AZH Wound & Hyperbaric Center

Publications:
Phillips, P., Wolcott, R., Fletcher, J. & Schultz, G. S. Biofilms made easy. Wounds Int. 2010 1, 1-6.

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Responsible Party: Atteris Healthcare, LLC
ClinicalTrials.gov Identifier: NCT03198169     History of Changes
Other Study ID Numbers: 1.0
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Wounds and Injuries
Anti-Infective Agents
Anti-Bacterial Agents