Clinical trial NCT06028386: Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
Official title: A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-healing Wound
Diabetic Foot Ulcer
Keywords: DFU
self-assembling peptide
chronic wounds
Synthetic matrix
Lead sponsor: Arch Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females aged 18 or older.
2. Subject is willing to sign informed consent and participate in all procedures with follow up evaluations as necessary to complete the study.
3. Study ulcer is diabetic in origin, located on the foot or below the malleolus with ulcer extending through the dermis but not into tendon, muscle or bone (UT Grade 1A).
4. Study ulcer size is a minimum of 2 cm2 and maximum 25 cm2 after the run-in period.
5. Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old, with documented failure of prior treatment to heal the wound.
6. Study ulcer has been offloaded for at least 14 days prior to randomization.
7. A two-week run-in period will precede enrollment in the trial to document the indolent nature of the subjects selected; healing rate is not to be \> 40% during this period.
8. Subject does not exhibit clinical signs / symptoms of infection upon gross observation or have been diagnosed with an active infection at time of screening.
9. Subject has adequate control of diabetes demonstrated by Hemoglobin A1c \< 12% within 90 days of screening.
10. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:

    * Dorsal transcutaneous oxygen measurements (TCOM) ≥ 30mmHg.
    * Ankle-Brachial Index with results of ≥ 0.8 and ≤ 1.5 or had past intervention.

Exclusion Criteria:

1. Study ulcer wound surface is area greater than 25 cm2.
2. Study ulcer has \> 40% wound healing during the 14 days screening period.
3. Subject has a known history of poor compliance with medical treatments.
4. Subject is presently participating in another clinical trial.
5. Subject has a known or suspected local malignancy to the Study diabetic ulcer, or systemic malignancy.
6. Subject has been diagnosed with autoimmune connective tissues diseases.
7. Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
8. Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
9. Subject is pregnant or breast feeding.
10. Subject is on dialysis.
11. Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
12. Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement.
13. Subject has a known allergy to ingredients/components of AC5.
14. Subject has osteomyelitis, and/or bony prominences present in the wound.
15. Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
16. Subject is unable to comply with planned study procedures and treatments.

Primary outcomes:
measure: Percentage of wounds closed
timeFrame: before or at 12 weeks
measure: Change in wound area size
timeFrame: from randomization through to end of study (at 12 weeks) for non-closed wounds
measure: Days to complete wound closure
timeFrame: before or at 12 weeks
Secondary outcomes:
measure: Number of units used to achieve wound closure
timeFrame: before or at 12 weeks
measure: Changes in quality of life
timeFrame: before or at 12 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Dr. Christopher Gauland
state: North Carolina
city: Circleville
country: United States
facility: Dr. Brock Liden
state: Ohio
Study officials:
affiliation: WAFL, Inc.
name: Brock Liden, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warriner RA, Snyder RJ, Cardinal MH. Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011 Dec;8(6):632-7. doi: 10.1111/j.1742-481X.2011.00860.x. Epub 2011 Sep 23.
citation: Rahmani G, Prats J, Norchi T, Kates S, McInerney V, Woods J, Kelly J. First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision. Dermatol Surg. 2018 Jul;44(7):939-948. doi: 10.1097/DSS.0000000000001468.
citation: Koutsopoulos S. Self-assembling peptide nanofiber hydrogels in tissue engineering and regenerative medicine: Progress, design guidelines, and applications. J Biomed Mater Res A. 2016 Apr;104(4):1002-16. doi: 10.1002/jbm.a.35638. Epub 2016 Jan 25.
citation: Kapp D, Pfendler L, D'Oro L, Wolcott R. Early clinical performance of an adaptive self-assembling barrier scaffold in nonhealing chronic wounds: a review of six cases. Wounds. 2022 Jan;33(1):20-30. doi: 10.25270/wnds/2022.2030.