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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Chronic Wounds

In brief

This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.

Key facts

Study ID

NCT03198169

Run by

Atteris Healthcare, LLC

People needed

4

Starts

2017-07-25

Expected to finish

2017-09-30

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• AZH Wound & Hyperbaric Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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