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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02375802
Eligibility Criteria:
Inclusion Criteria
* Males and females
* Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).
* Inpatient or outpatient treatment of pressure ulcers
* Diabetic Foot Ulcer Stage 1 or 2 of any size
* Co-morbidities may include:
* Peripheral Vascular Disease (PVD)
* Coronary Artery Disease (CAD)
* Chronic Renal Disease (CRD)
* Chronic Liver Disease (CLD)
* Hypertension (HTN)
* Diabetes
* The ability of subjects to give appropriate consent or have an appropriate representative available to do so
* The ability of subjects to return for weekly wound assessments
Exclusion Criteria
* Patients with allergies to TISSEEL, Tegaderm, or silicon
* Diabetics with poor glucose metabolic control (HbA1c \> 9)
* Target wounds that are in close proximity to potential cancerous lesions
* Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening
* Wounds located on the face
* Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)
* Wounds caused by diabetes mellitus (diabetic foot ulcers).
* BMI of \<16 Clinical signs of critical colonization or local infection
* Prolonged (\> 6 months) use of steroids
* Patients on active regimen of chemotherapy
* Patients receiving radiation in proximity of wound
* Decompensated chronic liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02375802
Study Brief:
Protocol Section:
NCT02375802