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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Macrocure Ltd.
Sponsor:
Collaborators:
Amarex Clinical Research
ICON Laboratories
ARANZ Medical
Information provided by (Responsible Party):
Macrocure Ltd.
ClinicalTrials.gov Identifier:
NCT01421966
First received: August 21, 2011
Last updated: May 1, 2014
Last verified: May 2014
  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® 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.


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 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

Resource links provided by NLM:


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:
  • Time to complete closure of the Target Ulcer during the core double blind treatment phase 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 with at least 50% closure of target ulcer during the 16-week core treatment period. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit. [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CureXcell® Biological: CureXcell®
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
Sham Comparator: Sham injection 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 3 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 280 patients, in approximately 35 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 Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control.

The study has two phases: a core double-blind phase and a follow up phase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females at least 18 years of age with diabetes type 1 or type 2;
  2. Patients with HbA1c ≤ 12%;
  3. Patients with at least one lower extremity (on or below the malleolus (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 more 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 for any reason including radiation therapy, chemotherapy or HIV;
  6. Current clinical osteomyelitis;
  7. Acute Charcot foot;
  8. Current sepsis;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421966

Contacts
Contact: Kush Dhody 301-956-2536 kushd@amarexcro.com

  Show 38 Study Locations
Sponsors and Collaborators
Macrocure Ltd.
Amarex Clinical Research
ICON Laboratories
ARANZ Medical
Investigators
Principal Investigator: Vickie Driver, MS, DPM, FACFAS VA New England Health Care Division
  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: May 1, 2014
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 August 26, 2014