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

Not Applicable

Recruiting

• Conditions: Non-healing Wound; Diabetic Foot Ulcer
• Interventions: Device: Fibracol Plus Collagen Dressing; Device: AC5® Advanced Wound System

• Registration Number: NCT06028386
• Lead Sponsor: Arch Therapeutics

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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-15
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-04-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm2- Fibracol Plus Collagen dressing	Fibracol Plus Collagen Dressing	The intervention in this arm is the application of collagen dressings to UT Grade 1A diabetic foot ulcers
Arm 1-AC5® Advanced Wound System	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of units used to achieve wound closure	before or at 12 weeks	number of units used
Changes in quality of life	before or at 12 weeks	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.

Trial Locations

Locations (2)

Dr. Christopher Gauland; 🇺🇸 Greenville, North Carolina, United States

Dr. Brock Liden; 🇺🇸 Circleville, Ohio, United States