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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02148302
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years old.
2. Adequate arterial flow (Ankle Brachial Pressure Index (ABI) \> 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms), OR Skin Perfusion Pressure (SPP) \>30, OR biphasic PVR OR TBI \> 0.60 OR TCPO2 \> 30mmHg OR adequate perfusion as demonstrated on florescent angiography, LUNA®).
3. Presence of a venous leg ulcer through full skin thickness but not down to muscle, tendon or bone. The largest ulcer will be the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
4. Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
5. Study ulcer is a minimum of 2.0 cm2 / maximum of 25 cm2 at the randomization visit.
6. The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
7. Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
8. Patient understands / is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
9. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Exclusion Criteria:
Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
1. Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, and ulcerations due to arterial insufficiency.
2. Study ulcer exhibits clinical signs and symptoms of infection at the SV (screening visit) or TV1 (Treatment Visit 1).
3. Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
4. Study ulcer is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. The patient may be enrolled after a negative biopsy.
5. Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
6. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, meristem) within the last 30 days
7. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
8. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
9. Pregnant or breast feeding.
10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of Human Immunodeficiency Virus (HIV).
11. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 10%.
12. Ulcers that have healed more than 40% during the screening phase are excluded.
13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening (i.e. S1); or patient or physician anticipates use of any of these therapies by the subject during the course of the study.
14. History of radiation at ulcer site.
15. Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study.
16. Patients who are unable to understand the aims and objectives of the trial.
17. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02148302
Study Brief:
Protocol Section:
NCT02148302