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

NCT03198169 | Terminated FDA Device

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Infective episodes

  6 weeks

• Pain

  6 weeks

• Wound Dimension Decreases

  6 and 12 weeks

Study Arms (4)

Active AWC + Active ABFD

EXPERIMENTAL

Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC

Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing

Active AWC + Placebo ABFD

EXPERIMENTAL

Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC

Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing

Placebo AWC + Active ABFD

EXPERIMENTAL

Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC

Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing

Placebo AWC + Placebo ABFD

EXPERIMENTAL

Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC

Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing

Interventions

Atteris Antimicrobial Skin and Wound Cleanser DEVICE

Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

Active AWC + Active ABFD; Active AWC + Placebo ABFD; Placebo AWC + Active ABFD; Placebo AWC + Placebo ABFD

Atteris Antimicrobial Barrier Film Dressing DEVICE

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.

Active AWC + Active ABFD; Active AWC + Placebo ABFD; Placebo AWC + Active ABFD; Placebo AWC + Placebo ABFD

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atteris Healthcare, LLC: lead
• Rochal Industries LLC: collaborator

Study Sites (1)

AZH Wound & Hyperbaric Center

Milwaukee, Wisconsin, 53221, United States

Location

Related Publications (11)

• 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.

  PMID: 19903300 BACKGROUND

• 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.

  PMID: 15147991 BACKGROUND

• 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.

  PMID: 19152648 BACKGROUND

• 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.

  PMID: 23742279 BACKGROUND

• 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.

  PMID: 26339534 BACKGROUND

• Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.

  PMID: 15021046 BACKGROUND

• 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.

  PMID: 18211576 BACKGROUND

• 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.

  PMID: 26340818 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17651490 BACKGROUND

• 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.

  PMID: 28654304 BACKGROUND

Study Officials

• Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS

  AZH Wound & Hyperbaric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: July 25, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: April 6, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)