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

Chronic Wounds Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03198169
• Other study ID #: 1.0
• Status: Terminated
• Phase: N/A
• First received: June 22, 2017
• Last updated: April 4, 2018
• Start date: July 25, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2017
• Source: Atteris Healthcare, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Wounds
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	AZH Wound & Hyperbaric Center	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Atteris Healthcare, LLC	Rochal Industries LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. Review. — View Citation

Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. Review. — View Citation

Game FL, Attinger C, Hartemann A, Hinchliffe RJ, Löndahl 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. — View 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. — View 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. Review. — View 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. — View Citation

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

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. Review. — View 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. — View Citation

Wicke C, Bachinger A, Coerper S, Beckert S, Witte MB, Königsrainer 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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