Chronic WoundsNCT03198169
A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.
A study testing Atteris Antimicrobial Skin and Wound Cleanser and Atteris Antimicrobial Barrier Film Dressing in people with Chronic Wounds, run by Atteris Healthcare, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Atteris Antimicrobial Skin and Wound Cleanser and Atteris Antimicrobial Barrier Film Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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
- 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
- Subjects with known alcohol or substance abuse within 6 months of screening
- Subjects with known allergy to PHMB, acrylate polymer and silicone
- Pregnancy or breastfeeding at time of screening
- Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
AZH Wound & Hyperbaric Center
Milwaukee, Wisconsin, 53221
About this study
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
This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.
Read the 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).
- Conditions
- Chronic Wounds
- Being tested
- Atteris Antimicrobial Skin and Wound Cleanser, Atteris Antimicrobial Barrier Film Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atteris Antimicrobial Skin and Wound CleanserDevice
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 DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active AWC + Active ABFD | Experimental | Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC Receives: 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 Receives: 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 Receives: 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 Receives: Device: Atteris Antimicrobial Skin and Wound Cleanser; Device: Atteris Antimicrobial Barrier Film Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Closure
Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)
Measured: 6 weeks of active treatment
Secondary outcomes (3)
Infective episodes
The number of infective episodes for which oral or IV antibiotics are prescribed
Measured: 6 weeks
Pain
Pain as reported using a Wong Baker Scale
Measured: 6 weeks
Wound Dimension Decreases
The percentage change in wound size relative to the baseline measurement
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start25 Jul 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Why it stopped: Inconsistent results in pilot phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atteris Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rochal Industries LLC
- Responsible party
- Sponsor
- Investigators
- Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS, Principal investigator, AZH Wound & Hyperbaric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198169
- Sponsor's protocol ID
- 1.0
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19903300Gottrup 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.
PubMed 15147991Wicke 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.
PubMed 19152648Richmond 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.
PubMed 23742279Frykberg 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.
PubMed 26339534Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.
PubMed 15021046Davis 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.
PubMed 18211576Game 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.
PubMed 26340818Phillips, 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.
PubMed 17651490Niederauer 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.
PubMed 28654304
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03198169
- Acronym / sponsor ID
- 1.0
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inconsistent results in pilot phase
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Atteris Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rochal Industries LLC
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active AWC + Active ABFD | Experimental | Device: Atteris Antimicrobial Skin and Wound Cleanser, Device: Atteris Antimicrobial Barrier Film DressingActive Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC |
| Active AWC + Placebo ABFD | Experimental | Device: Atteris Antimicrobial Skin and Wound Cleanser, Device: Atteris Antimicrobial Barrier Film DressingActive Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC |
| Placebo AWC + Active ABFD | Experimental | Device: Atteris Antimicrobial Skin and Wound Cleanser, Device: Atteris Antimicrobial Barrier Film DressingPlacebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC |
| Placebo AWC + Placebo ABFD | Experimental | Device: Atteris Antimicrobial Skin and Wound Cleanser, Device: Atteris Antimicrobial Barrier Film DressingPlacebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atteris Antimicrobial Skin and Wound CleanserWounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings. | Device | Active AWC + Active ABFD, Active AWC + Placebo ABFD, Placebo AWC + Active ABFD, Placebo AWC + Placebo ABFD |
| Atteris Antimicrobial Barrier Film DressingWounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings. | Device | Active AWC + Active ABFD, Active AWC + Placebo ABFD, Placebo AWC + Active ABFD, Placebo AWC + Placebo ABFD |
Primary outcome
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)
3 secondary outcomes
Infective episodes
Time frame: 6 weeks
Pain
Time frame: 6 weeks
Wound Dimension Decreases
Time frame: 6 and 12 weeks
Results and safety
The study was stopped early (reason given: Inconsistent results in pilot phase). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 19903300Sen 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.
- Background: PubMed 15147991Gottrup 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.
- Background: PubMed 19152648Wicke 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.
- Background: PubMed 23742279Richmond 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.
- Background: PubMed 26339534Frykberg 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.
- Background: PubMed 15021046Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.
- Background: PubMed 18211576Davis 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.
- Background: PubMed 26340818Game 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.
- BackgroundPhillips, P., Wolcott, R., Fletcher, J. & Schultz, G. S. Biofilms made easy. Wounds Int. 2010 1, 1-6.
- Background: PubMed 17651490Herber 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.
- Background: PubMed 28654304Niederauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS principal investigator
AZH Wound & Hyperbaric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atteris Antimicrobial Skin and Wound Cleanser and Atteris Antimicrobial Barrier Film Dressing in people with Chronic Wounds, run by Atteris Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inconsistent results in pilot phase). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Closure (time frame: 6 weeks of active treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198169, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.