Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT01596920. 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
A Multicenter, Adaptive Design, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Grafix® for the Treatment of Chronic Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator. Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.
Study identification
- NCT ID
- NCT01596920
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Apr 2012 (Type not available)
- Primary completion
- Aug 2013 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Apr 9, 2014
2012 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute for Advanced Wound Care at Baptist Medical | Montgomery | Alabama | 36111 | — |
| Clinical Trials of Arizona, Inc. | Glendale | Arizona | 85306 | — |
| ILD Laser and Research Center | Encinitas | California | 92024 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| River City Clinical Research | Jacksonville | Florida | 32207 | — |
| Aiyan Diabetes Center | Evans | Georgia | 30809 | — |
| Ocean County Foot and Ankle Surgical Associates | Toms River | New Jersey | 08753 | — |
| UNC at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Blair Orthopedics Associates, Inc | Altoona | Pennsylvania | 16602 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| Clincal Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01596920, 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 Apr 9, 2014 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01596920 live on ClinicalTrials.gov.