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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT02074995
Eligibility Criteria:
Inclusion Criteria:
* Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
* Dosing must occur within 8-12 days post-burn
* Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study
Exclusion Criteria:
* Spinal cord injury
* Hypoxic brain injury (Glasgow Coma Scale (GCS) \<8) at screening
* True conductive electric burn with suspected neurologic injury
* Uncontrolled diabetes with HbA1c \> 10% at screening, or known history of hypoglycemia,
* History of or active peripheral neuropathy or seizure disorder
* Systemic corticosteroids : \> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02074995
Study Brief:
Protocol Section:
NCT02074995