Treatment of diabetic foot ulcers using AC5® Advanced Wound System
A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
This study is testing whether the AC5® Advanced Wound System can help heal diabetic foot ulcers better than standard care treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arch Therapeutics Industry-sponsored |
| Locations | 2 sites (Greenville, North Carolina and 1 other locations) |
| Trial ID | NCT06028386 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation aims to compare the outcomes of patients with diabetic foot ulcers treated with the AC5® Advanced Wound System against those receiving standard advanced care. The study is a prospective, multi-center randomized controlled trial where participants will receive either the AC5 treatment or Fibracol Plus collagen dressing as part of their standard care. All subjects will undergo standard wound care procedures, and outcomes will be assessed at the end of the study to determine the effectiveness of the AC5 system in promoting healing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with diabetic foot ulcers that have not healed despite prior treatment.
Not a fit: Patients with ulcers showing signs of infection or those with ulcers not meeting the specified size and duration criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers.
How similar studies have performed: Other studies have shown promise with similar advanced wound care approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Greenville, North Carolina and 1 other locations
- Dr. Christopher Gauland — Greenville, North Carolina, United States (Not_yet_recruiting)
- Dr. Brock Liden — Circleville, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brock Liden, DPM — WAFL, Inc.
- Study coordinator: Evelyn Quintin
- Email: equintin@archtherapeutics.com
- Phone: 6174312308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.