Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Chronic Venous Leg Ulcers Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02130310
Study type	Interventional
Source	Macrocure Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	May 2014
Completion date	June 2016

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See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT00797706` - Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers	Phase 1/Phase 2
Recruiting	`NCT00678847` - Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy	Phase 2/Phase 3
Terminated	`NCT02936128` - TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers	Phase 4
Recruiting	`NCT03576989` - Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults	N/A