RECRUITING

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

Conditions

Non-healing Wound Diabetic Foot Ulcer DFU self-assembling peptide chronic wounds Synthetic matrix

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-15

Study Completion:2024-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06028386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Evelyn Quintin

CONTACT

6174312308

equintin@archtherapeutics.com

Terry Norchi, MD

CONTACT

800-937-9030

tnorchi@archtherapeutics.com

Principal Investigator

Brock Liden, DPM

PRINCIPAL_INVESTIGATOR

WAFL, Inc.

Study Locations (Sites)

Dr. Christopher Gauland

Greenville, North Carolina, 27834

United States

Dr. Brock Liden

Circleville, Ohio, 44113

United States

Collaborators and Investigators

Sponsor: Arch Therapeutics

Brock Liden, DPM, PRINCIPAL_INVESTIGATOR, WAFL, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15

Study Completion Date2024-08-30

Study Record Updates

Study Start Date2023-08-15

Study Completion Date2024-08-30

Terms related to this study

Keywords Provided by Researchers

DFU
self-assembling peptide
chronic wounds
Synthetic matrix

Additional Relevant MeSH Terms

Non-healing Wound
Diabetic Foot Ulcer