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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00847002
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be at least 18 years old
2. The ulcer maximum length x its maximum width must be greater or equal to 0 cm2
3. The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
4. The ulcer must have been present for more than 1 month.
5. The ulcer must be located below the knee.
6. The ulcer bed must have some viable tissues with some granulation tissue.
Exclusion Criteria:
1. Exposed bone, tendon, or fascia
2. Severe rheumatoid arthritis
3. History of radiotherapy to the ulcer site
4. Uncontrolled congestive heart failure
5. Receiving corticosteroids or immune suppressive therapy
6. History of collagen vascular disease
7. Known malnutrition (albumin\<3.0 g/dL). If malnutrition is suspected, the albumin level should be checked to determine if the patient meets the albumin criterion.
8. The ulcer is clinically infected. However, patients may be entered into the study after successful treatment of infection.
9. Known uncontrolled diabetes (HgbA1c \> 8%). If uncontrolled diabetes is suspected, the Hgb A1c should be checked to determine patient eligibility.
10. Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
11. Known arterial insufficiency (Ankle-brachial index \< 0.7, or TcPO2 \< 35 mm Hg, or Toe-brachial index \< 0.4). If peripheral vascular disease is suspected, vascular lab testing should be checked to determine patient eligibility.
12. Active sickle cell disease
13. Unable to comply with the procedures described in the protocol
14. Enrolled in a clinical evaluation for another investigational wound-care device or drug
15. Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months
16. Pregnancy, suspected or confirmed
17. Chronic renal disease, if deemed by the principal investigator to be severe enough to interfere with wound healing
18. Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy
19. History or pulmonary embolism
20. Poorly controlled asthma
21. Pulmonary Edema
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00847002
Study Brief:
Protocol Section:
NCT00847002