The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of care. Patient outcomes will be compared at the end of the study.
This study is a prospective, multi-center randomized controlled study designed to collect patient outcomes data for the treatment of diabetic foot ulcers. (DFU) All subjects will receive standard of care procedures (SOC) such as wound cleaning, appropriate sharp debridement, and appropriate offloading of the DFU (e.g., offloading Camboot or post op shoe with offloading/wound care insole). Subjects will be randomized and receive treatments to either of the following arms: Arm 1 - Subject will receive SOC that will include AC5® Advanced Wound System as an active synthetic cellular tissue product, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. AC5 will be applied weekly and outer dressings will be redressed, if necessary, using the allowed secondary dressings. Arm 2 - Subject will receive SOC that will include Fibracol Plus collagen dressing as an active dressing. This will be followed with an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap as needed. Fibracol Plus will be applied 3 x a week and any outer dressings will be redressed, if necessary, using the allowed dressings. The study involves two phases: Screening and Treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
This group will receive AC5® Advanced Wound system, a synthetic self-assembling peptide matrix to the wound and covered with non-adherent dressing followed with appropriate outer dressing to maintain moisture balance. AC5 is applied weekly and outer dressing will be redressed as necessary.
This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.
Dr. Christopher Gauland
Greenville, North Carolina, United States
NOT_YET_RECRUITINGDr. Brock Liden
Circleville, Ohio, United States
RECRUITINGPercentage of wounds closed
100% epithelialization
Time frame: before or at 12 weeks
Change in wound area size
Assess the percent change in wound area
Time frame: from randomization through to end of study (at 12 weeks) for non-closed wounds
Days to complete wound closure
median and mean
Time frame: before or at 12 weeks
Number of units used to achieve wound closure
number of units used
Time frame: before or at 12 weeks
Changes in quality of life
Pain, odor, itch intensity and activities of daily living are assessed before any ulcer manipulations. Subject will fill out the quality of life form which utilizes a numeric scale from 0 (minimum) to indicate no pain, no odor, no itch, normal activities of daily living -10 (maximum) to indicate worst possible pain, extremely strong odor, worst possible itch and not able to perform activities of daily living.
Time frame: before or at 12 weeks
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