Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
Public ClinicalTrials.gov record NCT04185558. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi-Center, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of ActiGraft Pro™ to Standard of Care in Patients With Chronic Neuropathic Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
* 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.
Study identification
- NCT ID
- NCT04185558
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 119 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 19, 2019
- Primary completion
- Mar 30, 2024
- Completion
- Mar 31, 2024
- Last update posted
- May 13, 2024
2019 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute for Advanced Wound Care | Montgomery | Alabama | 36111 | — |
| New Hope Podiatry Group Inc | Los Angeles | California | 90063 | — |
| Greater Los Angeles VA | Los Angeles | California | 90073 | — |
| Center for Clinical Research Inc | San Francisco | California | 94117 | — |
| Olive View UCLA Education & Research Institute | Sylmar | California | 91342 | — |
| Eric J Lullove DPM PA | Coconut Creek | Florida | 33073 | — |
| Future Health Research Clinic | Miami | Florida | 33175 | — |
| Barry University Clinical Research | North Miami Beach | Florida | 33169 | — |
| Pacific Vascular Institute | Hilo | Hawaii | 96720 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Wahab Consulting and Research LLC | Las Vegas | Nevada | 89148 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04185558, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04185558 live on ClinicalTrials.gov.