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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00368602
Eligibility Criteria:
Inclusion Criteria:
* Any race btwn 18 and 85 years of age, inclusive;
* Male or female, neither pregnant nor lactating.
* Informed consent;
* Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):
1. Surface area of ≥2 sq. cm. to ≤20 sq. cm.; Ulcer with largest surface area meeting inclusion criteria will be selected.
2. If 2 ulcers present with the same surface area, ulcer of longest duration selected.
3. Study ulcer must be at least 2 cm from any other ulcer on same extremity.
4. A viable wound bed free of necrotic tissue post-debridement, if debridement is indicated.
5\. Have an Ankle Brachial Index (ABI) \>0.7; 6. Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity; 7. Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study; 8. Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization; 9. Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;
Exclusion Criteria:
* Decrease in wound surface area of \>35% btwn Screening and Visit 1 (Randomization);
* Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;
* Grade IV ulcer;
* Evidence of study ulcer infection;
* Study ulcer of non-venous etiology;
* Acquired or are known to be infected with HIV;
* Uncontrolled diabetes mellitus;
* Immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal;
* Severe protein malnutrition as defined by serum albumin \<2.5 g/dL;
* Severe anemia defined as a total of hemoglobin of \<10 g/dL for males or \<8 g/dL for females;
* Chronic renal insufficiency requiring dialysis;
* Serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal;
* New York Heart Association Functional Classification of IV;
* Deep vein thrombosis (DVT) w/in last 6 weeks or clinical evidence of current DVT;
* Arterial revascularization of the study extremity w/in previous 6 months from the date of Screening Visit;
* History, w/in previous 12 months from date of Screen Visit, of alcohol or drug abuse, particularly methadone or heroin;
* Received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
* Received previous treatment with systemic corticosteroids prior to Screening (Chronic corticosteroids w/in 90 days or short course corticosteroids w/in 30 days)
* Been hospitalized for treatment of any venous ulcer w/in the previous 30 days from Screening.
* Asthma or a history of asthma, obstructive pulmonary disease, myasthenia gravis, hyperthyroidism, history of heart block
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00368602
Study Brief:
Protocol Section:
NCT00368602