The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds

A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds

The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities.

Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Biological: Activated allogeneic white blood cells

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Omer Clalit Clinic
  • Be'er-Sheva, Israel
    • Sold Clalit Clinic
  • Jerusalem, Israel
    • Hamoshava Diabetic Wound Clinic
  • Jerusalem, Israel
    • Ramat Eshcol Wound Clinic
  • Kiryat Bialik, Israel
    • Zvulun Wound Clinic
  • Petach Tikva, Israel
    • Hasharon Medical Center
  • Tel Aviv, Israel
    • Zamenhoff Wound Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.

Description

Inclusion Criteria:

1. Patients between 18 and 90 years of age with one ulcer that has not shown signs of normal healing (according to physician experienced in wound therapy) for more than 3 weeks
2. The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound.
3. In patients with suspected malnutrition albumin > 2.5 g/dL in blood tests performed within the last three weeks.
4. Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI > 0.6.
5. Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press).
6. Use of elastic bandaging in wounds due to venous insufficiency (when there is no involvement of an arterial problem).
7. Wound condition does not immediately jeopardize the extremity.
8. The patient's life is not at risk (for any reason).
9. The Patient has a life expectancy of at least one year.
10. Women of childbearing potential must be willing to use reliable methods of birth control.
11. Willing and able to sign an informed consent form and attend the follow up according to the treating staff instructions until complete wound closure.

Inclusion criteria in the 'treatment blinding guessing test':

1. A patient suffering from diabetes and a chronic ulcer in the lower extremity (ankle and below) and is CureXcell™ -naive.
2. Signing an appendix to the consent form for the 'treatment blinding guessing test'.

Exclusion Criteria:

1. More than one wound;
2. Inadequately treated recurrent pressure components in the wound. If required, ulcer will be treated with preliminary treatment for local pressure components (shoes and even cast or wheel chair for the treatment period)
3. Neoplastic ulcer
4. A patient with active malignant disease during the last five years, except for a patient suffering from adequately treated Basal Cell Carcinoma which does not present in the wound area.
5. Sepsis
6. Confirmed osteomyelitis
7. Patients suffering from significant immunosuppression.
8. INR > 3 in patients receiving anticoagulation drugs, in blood tests performed within two weeks prior to the first injection
9. A response to previous blood infusions (in case administered)
10. Patient receiving unique blood components (radiated, washed etc.)
11. Pregnant patient
12. Wounds for more than a year
13. A fistula/cavity which anatomical shape does not enable a direct injection into the wound
14. A patient participating in another clinical trial, or who participated in another clinical trial within the last 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hard to heal wounds

Biological: Activated allogeneic white blood cells; The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).; Other Names: CureXcell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with complete wound closure	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Median time to complete wound closure	End of study
Change in wound area between Baseline and Last Observation	End of study
Rate of wound infections, cellulitis, and osteomyelitis	End of study

Collaborators and Investigators

• Sponsor: Macrocure Ltd.
• Investigators: Principal Investigator: Ram Avrahami, MD, Clalit health services; Principal Investigator: David Snir, MD, Clalit health services; Principal Investigator: Yibgeni Sherman, MD, Clalit health services; Principal Investigator: David Vigoda, MD, Clalit health services; Principal Investigator: Dimitri Gimelreich, MD, Clalit health services; Principal Investigator: Asher Corcos, MD, Clalit health services; Principal Investigator: Laios Kazir, MD, Clalit health services

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (Estimate): April 29, 2010

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Chronic ulcers; diabetic foot ulcers; venous ulcers; pressure ulcers; post operative ulcers; hard to heal ulcers
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MC-103