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AC5® Advanced Wound System for Diabetic Foot Ulcers

Q: What is the size of the population participating in this research?

<p>Affirmative. The database on clinicaltrials.gov states that this research project, which was initially posted on August 15th 2023, is actively recruiting volunteers for participation. Approximately 60 participants must be recruited from 2 locations.</p>

Q: Is this research initiative currently recruiting participants?

<p>Affirmative. The details hosted on clinicaltrials.gov verify that this medical investigation is currently looking for participants, with the original posting occurring August 15th 2023 and the latest update being made September 7th of the same year. A total of 60 people must be recruited from two different sites.</p>

N/A

Recruiting

Led By Brock Liden, DPM

Research Sponsored by Arch Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 has been offloaded for at least 14 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before or at 12 weeks

Awards & highlights

Study Summary

This trial will compare outcomes of patients with diabetic foot ulcers treated with a FDA-cleared, self-assembling peptide to an advanced standard of care. Outcomes will be compared at the end of the study.

Who is the study for?

This trial is for adults with diabetic foot ulcers that are between 2 cm² and 25 cm² in size, have had the ulcer for at least 4 weeks but less than a year without significant healing, and have controlled diabetes (HbA1c <12%). Participants must not be on dialysis, taking immune-modulating drugs or have other health conditions like cancer or autoimmune diseases.Check my eligibility

What is being tested?

The study compares the effectiveness of AC5® Advanced Wound System—a self-assembling peptide dressing—to Fibracol Plus Collagen Dressing in treating Type 1A diabetic foot ulcers. Patient outcomes will be monitored to determine which treatment is more successful in wound care.See study design

What are the potential side effects?

Potential side effects were not explicitly listed; however, participants may experience reactions related to the wound dressings such as skin irritation, allergic reactions to ingredients/components of AC5®, or infection if proper care isn't followed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My foot ulcer is diabetic, not deep into muscle or bone.

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My ulcer has been properly cared for 14 days before the study.

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I do not have any signs of infection or an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before or at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before or at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and before or at 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in wound area size

Days to complete wound closure

Percentage of wounds closed

Secondary outcome measures

Changes in quality of life

Number of units used to achieve wound closure

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm 1-AC5® Advanced Wound SystemActive Control1 Intervention

The intervention in this arm is the application of a synthetic self assembling peptide matrix (AC5) to UT Grade 1A diabetic foot ulcers

Group II: Arm2- Fibracol Plus Collagen dressingPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arch TherapeuticsLead Sponsor

1 Previous Clinical Trials

46 Total Patients Enrolled

Brock Liden, DPMPrincipal InvestigatorWAFL, Inc.

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the population participating in this research?

"Affirmative. The database on clinicaltrials.gov states that this research project, which was initially posted on August 15th 2023, is actively recruiting volunteers for participation. Approximately 60 participants must be recruited from 2 locations."

Answered by AI

Is this research initiative currently recruiting participants?

"Affirmative. The details hosted on clinicaltrials.gov verify that this medical investigation is currently looking for participants, with the original posting occurring August 15th 2023 and the latest update being made September 7th of the same year. A total of 60 people must be recruited from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028386.