Status:
COMPLETED
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Lead Sponsor:
Macrocure Ltd.
Collaborating Sponsors:
Amarex Clinical Research
ICON plc
Conditions:
Lower Extremity Chronic Ulcers in Diabetics
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 purp...
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 w...
Eligibility Criteria
Inclusion
- Males or females at least 18 years of age with diabetes type 1 or type 2;
- Patients with HbA1c ≤ 12%;
- 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;
- 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);
- Ankle Brachial Index ≥ 0.65;
Exclusion
- Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
- Patients with ulcers primarily caused by venous insufficiency;
- Patients whose target ulcer has decreased \> 25% in size from screening to baseline;
- Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
- Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
- Current clinical osteomyelitis;
- Acute Charcot foot;
- Current sepsis;
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01421966
Start Date
August 1 2011
End Date
October 1 2015
Last Update
December 7 2015
Active Locations (37)
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1
Glendale, Arizona, United States
2
Mesa, Arizona, United States
3
Phoenix, Arizona, United States
4
Tucson, Arizona, United States