Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

Status unconfirmed · Not applicable

Conditions studied: Non-healing Wound, Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT06028386

Run by

Arch Therapeutics

People needed

60

Starts

2023-08-15

Expected to finish

2024-08-30

Last updated by the study team

2023-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 18 or older.
• Subject is willing to sign informed consent and participate in all procedures with follow up evaluations as necessary to complete the study.
• 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).
• Study ulcer size is a minimum of 2 cm2 and maximum 25 cm2 after the run-in period.
• 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.
• Study ulcer has been offloaded for at least 14 days prior to randomization.
• 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.
• Subject does not exhibit clinical signs / symptoms of infection upon gross observation or have been diagnosed with an active infection at time of screening.
• Subject has adequate control of diabetes demonstrated by Hemoglobin A1c < 12% within 90 days of screening.
• 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.

You may not qualify if…

• Study ulcer wound surface is area greater than 25 cm2.
• Study ulcer has > 40% wound healing during the 14 days screening period.
• Subject has a known history of poor compliance with medical treatments.
• Subject is presently participating in another clinical trial.
• Subject has a known or suspected local malignancy to the Study diabetic ulcer, or systemic malignancy.
• Subject has been diagnosed with autoimmune connective tissues diseases.
• Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
• Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
• Subject is pregnant or breast feeding.
• Subject is on dialysis.
• Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
• 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.
• Subject has a known allergy to ingredients/components of AC5.
• Subject has osteomyelitis, and/or bony prominences present in the wound.
• Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
• Subject is unable to comply with planned study procedures and treatments.

Where it is running

• Dr. Brock Liden — Circleville, Ohio, United States (enrolling)
• Dr. Christopher Gauland — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.