Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01421966
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01421966
Study Brief:
Protocol Section:
NCT01421966