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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04479618
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with HbSS or HbSβ0 sickle cell disease
* Ages 13 - 70 years at study initiation (able to comprehend and give consent)
* Males and females, pregnancy is not an issue
* Open wound below the knee, not including the plantar surface of the foot
* Wound open for longer than one month (defined as a chronic SCLU)
* Traumatic, spontaneous, or recurrent SCLU (all etiologies)
Exclusion Criteria:
* Patient younger than 13 years of age at study initiation
* Patient older than 70 years of age at study initiation
* Wound open for less than one month by conclusion of study enrollment period (acute wounds could be traumatic wounds unrelated to sickle cell diagnosis)
* Diagnosis of cancer, hypertension, or chronic renal failure
* Diabetes (will screen for undiagnosed diabetes)
* Active wound infection (evidenced by clinical signs of malodor, dark-colored or thick drainage, or significantly increased warmth at the periwound) which is not resolved by the conclusion of the study enrollment period
* Osteomyelitis (if osteomyelitis is suspected, an ESR will be drawn; \> 70mm/h with high platelet levels and low serum albumin warrants a bone biopsy)
* Hydroxyurea use (may be a confound because it reduces inflammation and negates much of the pathology of SSD - may choose to abstain for the study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
70 Years
Study:
NCT04479618
Study Brief:
Protocol Section:
NCT04479618