Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
|ClinicalTrials.gov Identifier: NCT02130310|
Recruitment Status : Unknown
Verified September 2015 by Macrocure Ltd..
Recruitment status was: Active, not recruiting
First Posted : May 5, 2014
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Leg Ulcers||Biological: CureXcell® Other: Placebo injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||June 2016|
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.
Placebo Comparator: Placebo injection
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
Other: Placebo injection
Normal saline injected at each centimeter of ulcer bed
- Time to complete closure of Target Ulcer [ Time Frame: up to 16 weeks ]Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
- Proportion of complete closure of Target Ulcer [ Time Frame: up to 16 weeks ]Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
- Percentage change from baseline in Target Ulcer surface area [ Time Frame: up to 12 weeks ]Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.
- Proportion of Target Ulcer recurrence [ Time Frame: up to 24 weeks ]Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
- Adverse Events [ Time Frame: up to 24 weeks ]Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130310
Show 28 Study Locations
|Principal Investigator:||Robert Kirsner, MD, PhD||University of Miami|
|Principal Investigator:||John Lantis, MD||St. Luke's-Roosevelt Hospital Center|
|Principal Investigator:||Robert Snyder, DPM||Barry University Clinical Research|