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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00273234
Eligibility Criteria:
Inclusion Criteria:
* Presence of venous insufficiency lower extremity (below knee) ulcer
* 4 weeks
* Area of ulcer is 1 cm2 - 20 cm2
* Subject is receiving standard wound care
* ABI ≥ 0.8 or, if diabetic, TBI ≥ 0.8 on the study limb.
* Subject has adequate venous access for phlebotomy.
* Subject has access to reliable outpatient dressing care (self, family member, nursing staff, etc.)
* Hematocrit is \> 30%
* Platelet Count is \> 100,000
* INR \< 1.3
* Subject has no known coagulopathies
* Serum Albumin \> 2.5
* If diabetic, HgbA1C \< 10%
* Venous reflux \< 20 seconds by ultrasonography
Exclusion Criteria:
* Presence of arterial insufficiency (ABI or if diabetic TBI \<0.8)
* Subject has received biological therapy within 30 days of enrollment
* Subject is receiving radiation therapy near the ulcer
* Active infection of the study wound, or osteomyelitis, or cellulitis has been diagnosed. The patient may be enrolled only after the infection has been controlled, including:
* Debridement if necessary
* Patient has received at least 2 weeks of appropriate antibiotics
* Allergy to bovine thrombin
* Alcohol or drug abuse within 6 months of enrollment
* Subject has been diagnosed with AIDS, HIV, or Hepatitis
* Subject is taking immunosuppressive therapy
* Subject is taking pentoxyfilline (Trental®)
* Steroid use within 7 days of enrollment
* Presence of a non-study ulcer within 2.0cm of the study ulcer
* Angioplasty by bypass or endovascular therapy within 4 weeks of enrollment
* Suspected sleep apnea
* Active Cancer
* BMI \> 40 kg/m2
* Severe Rheumatoid Arthritis
* Collagen vascular disease
* Female who is pregnant or lactating or not using a reliable birth control method if of child-bearing age
* Wound bed with exposed bone, tendon, or fascia
* Renal insufficiency defined as Creatinine \> 3 mg/dL
* Hepatic insufficiency defined as total Bilirubin \> 2 mg/dL
* Enrollment, within the past 3 months, in any study related to wound healing
* Closure of study wound ≥ 40% within 2 screening visits of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00273234
Study Brief:
Protocol Section:
NCT00273234