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

NCT06028386 | Unknown FDA Device

• 1 other identifier: CP-1003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Percentage of wounds closed

  100% epithelialization

  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

• Days to complete wound closure

  median and mean

  before or at 12 weeks

Secondary Outcomes (2)

• Number of units used to achieve wound closure

  before or at 12 weeks

• Changes in quality of life

  before or at 12 weeks

Study Arms (2)

Arm 1-AC5® Advanced Wound System

ACTIVE COMPARATOR

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

Arm2- Fibracol Plus Collagen dressing

PLACEBO COMPARATOR

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

Device: Fibracol Plus Collagen Dressing

Interventions

AC5® Advanced Wound System DEVICE

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.

Arm 1-AC5® Advanced Wound System

Fibracol Plus Collagen Dressing DEVICE

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

Arm2- Fibracol Plus Collagen dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Arch Therapeutics: lead

Study Sites (2)

Dr. Christopher Gauland

Greenville, North Carolina, 27834, United States

NOT YET RECRUITING

Dr. Brock Liden

Circleville, Ohio, 44113, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 21951763 BACKGROUND

• 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.

  PMID: 29381543 BACKGROUND

• 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.

  PMID: 26707893 BACKGROUND

• 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.

  PMID: 35108216 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Brock Liden, DPM

  WAFL, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Quintin

CONTACT

6174312308; equintin@archtherapeutics.com

Terry Norchi, MD

CONTACT

800-937-9030; tnorchi@archtherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: August 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)