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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT00632034
Eligibility Criteria:
Inclusion Criteria:
* Confirmed closed tibial fracture on one limb only
* Normal blood count
* Normal coagulation screen
* Life expectancy of at least 12 months
* Ability to give written informed consent
Exclusion Criteria:
* Patients with additional lower limb injuries
* Patients with abnormal lower limb vasculature
* Pregnant or lactating women
* Unexplained abnormal baseline laboratory results
* Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study
* Subjects who test positive for HTLV, HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications
* History of alcohol or drug abuse within 3 months of screening
* Subjects with evidence (clinical, laboratory, or imaging) of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma)
* Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period
* Patients unable to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
75 Years
Study:
NCT00632034
Study Brief:
Protocol Section:
NCT00632034