Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Public ClinicalTrials.gov record NCT01421966. 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 Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.
Study identification
- NCT ID
- NCT01421966
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 285 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Jul 31, 2011
- Primary completion
- Jan 31, 2015
- Completion
- Sep 30, 2015
- Last update posted
- Dec 6, 2015
2011 – 2015
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Glendale | Arizona | — | — |
| Not listed | Mesa | Arizona | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Fresno | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Sylmar | California | — | — |
| Not listed | Gulf Breeze | Florida | — | — |
| Not listed | Hialeah | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | South Miami | Florida | — | — |
| Not listed | Evans | Georgia | — | — |
| Not listed | Arlington Heights | Illinois | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Oak Park | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Toms River | New Jersey | — | — |
| Not listed | Mineola | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Lima | Ohio | — | — |
| Not listed | Aiken | South Carolina | — | — |
| Not listed | Greenville | South Carolina | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Lewisville | Texas | — | — |
| Not listed | McAllen | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01421966, 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 Dec 6, 2015 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01421966 live on ClinicalTrials.gov.