Non-healing WoundNCT06028386
Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
A study testing AC5® Advanced Wound System and Fibracol Plus Collagen Dressing in people with Non-healing Wound and Diabetic Foot Ulcer, run by Arch Therapeutics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-healing Wound, Diabetic Foot Ulcer
- What is being tested?
- AC5® Advanced Wound System and Fibracol Plus Collagen Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Subject is unable to comply with planned study procedures and treatments.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Dr. Brock Liden
Circleville, Ohio, 44113
Brock Liden, dpmresearch@gmail.com
- Not yet recruiting
Dr. Christopher Gauland
Greenville, North Carolina, 27834
Christopher Gauland, chris@ecfanc.com
About this 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
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.
Read the 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.
- Conditions
- Non-healing Wound, Diabetic Foot Ulcer
- Being tested
- AC5® Advanced Wound System, Fibracol Plus Collagen Dressing
- Keywords
- DFU, self-assembling peptide, chronic wounds, Synthetic matrix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC5® Advanced Wound SystemDevice
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.
Fibracol Plus Collagen DressingDevice
This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Fibracol Plus Collagen Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of wounds closed
100% epithelialization
Measured: before or at 12 weeks
Change in wound area size
Assess the percent change in wound area
Measured: from randomization through to end of study (at 12 weeks) for non-closed wounds
Days to complete wound closure
median and mean
Measured: before or at 12 weeks
Secondary outcomes (2)
Number of units used to achieve wound closure
number of units used
Measured: 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.
Measured: before or at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arch Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brock Liden, DPM, Principal investigator, WAFL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028386
- Sponsor's protocol ID
- CP-1003
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 21951763Rahmani 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.
PubMed 29381543Koutsopoulos 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.
PubMed 26707893Kapp 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.
PubMed 35108216
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06028386
- Acronym / sponsor ID
- CP-1003
- Conditions
- Non-healing Wound, Diabetic Foot Ulcer
- Keywords
- DFU, self-assembling peptide, chronic wounds, Synthetic matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arch TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1-AC5® Advanced Wound System | Active comparator | Device: AC5® Advanced Wound SystemThe intervention in this arm is the application of a synthetic self assembling peptide matrix (AC5) to UT Grade 1A diabetic foot ulcers |
| Arm2- Fibracol Plus Collagen dressing | Placebo comparator | Device: Fibracol Plus Collagen DressingThe intervention in this arm is the application of collagen dressings to UT Grade 1A diabetic foot ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC5® Advanced Wound SystemThis 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. | Device | Arm 1-AC5® Advanced Wound System |
| Fibracol Plus Collagen DressingThis group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week. | Device | Arm2- Fibracol Plus Collagen dressing |
Primary outcome
Percentage of wounds closed
Time frame: before or at 12 weeks
100% epithelialization
Change in wound area size
Time frame: from randomization through to end of study (at 12 weeks) for non-closed wounds
Assess the percent change in wound area
Days to complete wound closure
Time frame: before or at 12 weeks
median and mean
2 secondary outcomes
Number of units used to achieve wound closure
Time frame: before or at 12 weeks
Changes in quality of life
Time frame: before or at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 21951763Warriner 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.
- Background: PubMed 29381543Rahmani 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.
- Background: PubMed 26707893Koutsopoulos 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.
- Background: PubMed 35108216Kapp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brock Liden, DPM principal investigator
WAFL, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AC5® Advanced Wound System and Fibracol Plus Collagen Dressing in people with Non-healing Wound and Diabetic Foot Ulcer, run by Arch Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Quintin (6174312308, equintin@archtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of wounds closed (time frame: before or at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028386, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.