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

A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Non-healing Wound
• Intervention / Treatment: Device: AC5® Advanced Wound System; Device: Fibracol Plus Collagen Dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyn Quintin; Phone Number: 6174312308; Email: equintin@archtherapeutics.com
• Study Contact Backup: Name: Terry Norchi, MD; Phone Number: 800-937-9030; Email: tnorchi@archtherapeutics.com

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Not yet recruiting
      • Dr. Christopher Gauland
      • Contact: Christopher Gauland; Email: chris@ecfanc.com
  • Ohio
    • Circleville, Ohio, United States, 44113
      • Recruiting
      • Dr. Brock Liden
      • Contact: Brock Liden; Email: dpmresearch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: 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.
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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of wounds closed	100% epithelialization	before or at 12 weeks
Days to complete wound closure	median and mean	before or at 12 weeks
Change in wound area size	Assess the percent change in wound area	from randomization through to end of study (at 12 weeks) for non-closed wounds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of units used to achieve wound closure	number of units used	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.	before or at 12 weeks

Collaborators and Investigators

• Sponsor: Arch Therapeutics
• Investigators: Principal Investigator: Brock Liden, DPM, WAFL, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: DFU; chronic wounds; self-assembling peptide; Synthetic matrix
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries
• Other Study ID Numbers: CP-1003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No