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Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
NCT04185558 · View on ClinicalTrials.gov ↗
Study Summary
* The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers. * The subjects are randomized to receive 1 of 2 treatments, either with ActiGraft and standard of care (SOC) or with SOC alone. * The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of the ActiGraft + SOC or SOC until for up to 12 weeks or until the study ulcer has completely healed (i.e., 100% closure as assessed by the Investigator and blinded assessor and confirmed 2 weeks later at the healing confirmation visit (HCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the ActiGraft arm or (2) change the standard of care dressing in the control arm. * Immediately after the study ulcer is confirmed as completely healed, subjects will enter the 12-week Follow-up Phase. During the Follow-Up phase, subjects will be evaluated twice during the first month and then monthly for two additional visits every 4 weeks until the completion of the 12-week Follow-up Phase.
Conditions Studied
Interventions
- DEVICE ActiGraft
- DEVICE Standard of Care
Study Locations (16)
California
- New Hope Podiatry Group Inc — Los Angeles
- Greater Los Angeles VA — Los Angeles
- Center for Clinical Research Inc — San Francisco
- Olive View UCLA Education & Research Institute — Sylmar
Other
- Wound Care South Africa — Germiston
- Haute Care — Lyttelton
- Eloquent Health & Wellness — Tyger Valley
- Acinadem Altunizade — Istanbul
Florida
- Eric J Lullove DPM PA — Coconut Creek
- Future Health Research Clinic — Miami
- Barry University Clinical Research — North Miami Beach
Alabama
- Institute for Advanced Wound Care — Montgomery
Hawaii
- Pacific Vascular Institute — Hilo
Massachusetts
- Boston Medical Center — Boston
Nevada
- Wahab Consulting and Research LLC — Las Vegas
Pennsylvania
- Temple University — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04185558
The ClinicalTrials.gov registry entry for NCT04185558 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RedDress, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetic Foot appearing as the primary indexed condition, and to 2 interventions — of which ActiGraft is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04185558 reports 16 study locations spanning 8 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04185558 about?
NCT04185558 is a clinical study titled "Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs". * The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers. * The subjects are randomized to receive 1 of 2 treatments, either with ActiGraft and standard of care (SOC) or with SOC alone. * The target ulcers are ...
What is the current status of trial NCT04185558?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2019-12-20. Estimated completion is 2024-04-01.
What conditions does trial NCT04185558 study?
This clinical trial studies the following conditions: Diabetic Foot, Chronic Ulcer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04185558?
The interventions under investigation include: ActiGraft (DEVICE), Standard of Care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04185558?
This trial is sponsored by RedDress, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04185558 being conducted?
This trial has 16 study locations across Alabama, California, Florida, Hawaii, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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