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Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

NCT01421966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2015-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Lower Extremity Chronic Ulcers in Diabetics

Interventions

BIOLOGICAL

CureXcell®

CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.

BIOLOGICAL

Sham injection

The sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • ICON plc

    collaborator INDUSTRY

  • ARANZ Medical

    collaborator OTHER

  • Macrocure Ltd.

    lead INDUSTRY

Principal Investigators

  • Vickie Driver, MS, DPM, FACFAS · VA New England Health Care Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-02-28
Completion
2015-10-31

Countries

  • United States
  • Canada
  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421966 on ClinicalTrials.gov