Chronic Wounds
Conditions
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).
Interventions
DEVICEAtteris 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.
DEVICEAtteris 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.
Sponsors
Rochal Industries LLC
Atteris Healthcare, LLC
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Closure | 6 weeks of active treatment | Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infective episodes | 6 weeks | The number of infective episodes for which oral or IV antibiotics are prescribed |
| Pain | 6 weeks | Pain as reported using a Wong Baker Scale |
| Wound Dimension Decreases | 6 and 12 weeks | The percentage change in wound size relative to the baseline measurement |
Countries
United States
Outcome results
None listed