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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06873867
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be at least 18 years of age or older.
2. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².
3. Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
4. Adequate vascular supply to the affected area
5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
6. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
7. The subject must be willing and able to participate in the informed consent process.
Exclusion Criteria:
1. A subject known to have a life expectancy of \<6 months
2. Wounds with active infection / osteomyelitis requiring systemic antibiotics.
3. Presence of malignancy in the wound bed.
4. Patients with uncontrolled diabetes (HbA1c \> 9%).
5. Use of immunosuppressive therapy or systemic corticosteroids.
6. Use of other advanced wound care products within the past 30 days
7. Known allergy to fish products or components of HPTC.
8. Pregnant or breastfeeding women.
9. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
10. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
11. A subject with autoimmune or connective tissue disorders.
12. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06873867
Study Brief:
Protocol Section:
NCT06873867