Clinical trial NCT03198169: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Wounds
Lead sponsor: Atteris Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Rochal Industries LLC
First posted: 2017-06-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Complete Closure
timeFrame: 6 weeks of active treatment
Secondary outcomes:
measure: Infective episodes
timeFrame: 6 weeks
measure: Pain
timeFrame: 6 weeks
measure: Wound Dimension Decreases
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: AZH Wound & Hyperbaric Center
state: Wisconsin
Study officials:
affiliation: AZH Wound & Hyperbaric Center
name: Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.