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

Launched by MACROCURE LTD. · Aug 22, 2011

Keywords

ClinConnect Summary

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 heali...

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Eligibility 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;