Text Size

Evaluation of CureXcell™ in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes (CXC)

This study is currently recruiting participants.
Verified November 2012 by Macrocure Ltd.
Sponsor:
Collaborators:
Aptiv Solutions
ICON Laboratories
ARANZ Medical
Information provided by (Responsible Party):
Macrocure Ltd.
ClinicalTrials.gov Identifier:
NCT01421966
First received: August 21, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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™ (CXC)in treating chronic lower extremity ulcers in adults with diabetes mellitus. CXC is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 375 patients will be randomized to receive either CXC or sham.


Condition Intervention Phase
Lower Extremity Chronic Ulcers in Diabetics
 Biological: Curexcell
Biological: Sham injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multinational, 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 Measures in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Macrocure Ltd.:

Primary Outcome Measures:
  • Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients (and individual treated ulcers) with all ulcers completely healed/closed at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients (and individual treated ulcers) with at least 50% closure of target ulcer (and individual treated ulcers) during the16-week core treatment period. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Time to complete closure/healing of all ulcers (and individual treated ulcers) during the 16-week core treatment period with sustained complete closure for 4 additional weeks of follow-up [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
  • Time to complete closure/healing of the target ulcer during the 16-week core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients whose target ulcer (and individual treated ulcers) completely closed/healed during the 16-week core treatment period and remained closed at the Week 12 follow-up visit. [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients whose target ulcer (and individual treated ulcers) had ulcer recurrence following complete closure during the 16-week core treatment period and during the 12-week follow-up period [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: August 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curexcell Biological: Curexcell
CureXcell injection will be administered every 4 weeks until ulcer closure. Injections will be made superficially in the ulcer bed using a 23-27-G needle. The total volume of the treatment will depend on the ulcer area and depth; ~0.1 mL (2-4x105 cells) will be injected at each cm of the ulcer bed. The maximum dose for injection of ulcer is <4 mL.
Sham Comparator: 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
 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

Detailed Description:

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase III multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell™ in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.

CureXcell™ is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock.

A total of 375 patients, in approximately 25 sites in the US, Canada and Israel, will be randomized to receive either CureXcell™ or control.

The primary objective of the study is to evaluate the clinical benefit of CureXcell™ (study biologic) compared to control, as adjunct to GUC. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell™ compared to control.

The study has two phases: a core double-blind phase followed by an open-label phase. Both phases consist of treatment and follow up periods.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2;
  2. Patients with HbA1c ≤ 10%;
  3. Patients with at least one lower extremity ((on or below the malleoli(ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;
  4. Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);
  5. Ankle Brachial Index ≥ 0.65;

Exclusion Criteria:

  1. Patients with more than two ulcers on the same foot or greater than a total of three chronic ulcers;
  2. Patients with ulcers primarily caused by venous insufficiency;
  3. Patients whose target ulcer has decreased > 25% in size from screening to baseline;
  4. Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
  5. Significantly compromised immunity from any reason including radiation therapy, chemotherapy or HIV;
  6. Current clinical osteomyelitis;
  7. Acute Charcot foot;
  8. Current sepsis;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421966

  Show 23 Study Locations
Sponsors and Collaborators
Macrocure Ltd.
Aptiv Solutions
ICON Laboratories
ARANZ Medical
Investigators
Principal Investigator: Vickie Driver, DPM Boston University
Principal Investigator: Robert Frykberg, DPM Phoenix VA Medical Center
Principal Investigator: Richard Galperin, DPM South Hampton Community Hospital
Principal Investigator: Mark Iafrati, MD Tufts Medical Center
Principal Investigator: Robert Kirsner, MD University of Miami
Principal Investigator: John Lantis, MD St. Luke's-Roosevelt Hospital Center
Principal Investigator: Katherine Neiderer, DPM Southern Arizona VA Health Care System
Principal Investigator: Alexander Reyzelman, DPM Center for Clinical Research Incorporated
Principal Investigator: Jodi Walters, DPM Southern Arizona Limb Salvage Alliance
Principal Investigator: John York, MD Vascular Health Alliance
Principal Investigator: Robert J Snyder, DPM Barry University School of Podiatric Medicine
Principal Investigator: James McGuire, DPM Temple University
Principal Investigator: Marc Corriveau, MD McGill University Health Center
Principal Investigator: John Embil, MD Health Sciences Centre
Principal Investigator: Michael Robern, MD Office of Dr. Michael Robern
Principal Investigator: Asher-Prosper Corcos, MD Diabetic & Endocrinology Clinic General Health Services
Principal Investigator: Zeev Feldbrin, MD Wolfson Medical Center
Principal Investigator: Ilana Harman Boehm, MD Soroka Medical Center
Principal Investigator: Eyal Melamed, MD Rambam Health Care Campus
Principal Investigator: Itzhak Siev-Ner, MD Sheba Medical Center
Principal Investigator: Stephanie Wu, DPM Center for Lower Extremity Research, Rosalind Franklin University
Principal Investigator: Peter Balingit, MD University of California, Los Angeles
Principal Investigator: Lawrence Lavery, DPM University of Texas Southwestern University
Principal Investigator: Harold Brem, MD Winthrop University, Mineola MN
Principal Investigator: John Tassone, DPM Thunderbird Internal Medicine, Glendale AZ
Principal Investigator: Christina Morin, DPM Centre Podiatrique et Soin Des Plaies, Boucherville, Quebec
Principal Investigator: Ram Avrahami, MD TLM Medical Center, Tel Aviv Israel
  More Information

No publications provided

Responsible Party: Macrocure Ltd.
ClinicalTrials.gov Identifier: NCT01421966     History of Changes
Other Study ID Numbers: MC-102
Study First Received: August 21, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health

Keywords provided by Macrocure Ltd.:
chronic ulcers
diabetic foot ulcers

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013