Clinical trial NCT01113307: The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
Official title: A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: Chronic ulcers
pressure ulcers
venous ulcers
diabetic foot ulcers
post operative ulcers
hard to heal ulcers
Lead sponsor: Macrocure Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-29
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcers.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with complete wound closure
timeFrame: Week 24
Secondary outcomes:
measure: Median time to complete wound closure
timeFrame: End of study
measure: Change in wound area between Baseline and Last Observation
timeFrame: End of study
measure: Rate of wound infections, cellulitis, and osteomyelitis
timeFrame: End of study
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Omer Clalit Clinic
city: Be'er-Sheva
country: Israel
facility: Sold Clalit Clinic
city: Jerusalem
country: Israel
facility: Hamoshava Diabetic Wound Clinic
city: Jerusalem
country: Israel
facility: Ramat Eshcol Wound Clinic
city: Kiryat Bialik
country: Israel
facility: Zvulun Wound Clinic
city: Petach Tikva
country: Israel
facility: Hasharon Medical Center
city: Tel Aviv
country: Israel
facility: Zamenhoff Wound Clinic
Study officials:
affiliation: Clalit Health Services
name: Ram Avrahami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: David Snir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Yibgeni Sherman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: David Vigoda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Dimitri Gimelreich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Asher Corcos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Laios Kazir, MD
role: PRINCIPAL_INVESTIGATOR
References: