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

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

This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.

Study Overview

• Status: Terminated
• Conditions: Chronic Wounds
• Intervention / Treatment: Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53221
      • AZH Wound & Hyperbaric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Closure	Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)	6 weeks of active treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infective episodes	The number of infective episodes for which oral or IV antibiotics are prescribed	6 weeks
Pain	Pain as reported using a Wong Baker Scale	6 weeks
Wound Dimension Decreases	The percentage change in wound size relative to the baseline measurement	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Atteris Healthcare, LLC
• Collaborators: Rochal Industries LLC
• Investigators: Principal Investigator: Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS, AZH Wound & Hyperbaric Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.
• 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.
• 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.
• Phillips, P., Wolcott, R., Fletcher, J. & Schultz, G. S. Biofilms made easy. Wounds Int. 2010 1, 1-6.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2017
• Primary Completion (ACTUAL): September 30, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (ACTUAL): June 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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