Recruiting

AC5® Advanced Wound System

Sponsor:

Arch Therapeutics

Code:

NCT06028386

Conditions

Non-healing Wound

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AC5® Advanced Wound System

Fibracol Plus Collagen Dressing

Study Details

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.

Conditions

Non-healing Wound

Diabetic Foot Ulcer

Study ID

NCT06028386

Start date

Aug 15, 2023

Status verified date

Aug, 2023

Completion date

Aug 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1-AC5® Advanced Wound System

The intervention in this arm is the application of a synthetic self assembling peptide matrix (AC5) to UT Grade 1A diabetic foot ulcers

placebo comparator: Arm2- Fibracol Plus Collagen dressing

The intervention in this arm is the application of collagen dressings to UT Grade 1A diabetic foot ulcers

Interventions

AC5® Advanced Wound System

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.

Fibracol Plus Collagen Dressing

This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.

Primary outcome measure

  • Percentage of wounds closed [ Time Frame: before or at 12 weeks ]
  • Change in wound area size [ Time Frame: from randomization through to end of study (at 12 weeks) for non-closed wounds ]
  • Days to complete wound closure [ Time Frame: before or at 12 weeks ]

Central Contacts and Locations

Locations

Dr. Brock Liden

Recruiting

Circleville, Ohio, United States, 44113

Contacts

More Information

Sponsor

Arch Therapeutics

Last update posted

Sep 11, 2023

Last verified

Aug, 2023

Keywords

  • DFU
  • self-assembling peptide
  • chronic wounds
  • Synthetic matrix

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arch Therapeutics on 2023-09-11.