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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01549860
Eligibility Criteria:
Inclusion Criteria:
* Lower extremity full thickness venous ulcer of \> 30 days duration
* Subject's wound must be between 4 cm² and 50 cm² at screening
* Documented ABI that is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) \> 40 mmHG; or a toe pressure \> 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at time of screening
* Biopsy for wounds \> 6 months duration
* Documented index wound etiology of venous stasis with reflux and /or incompetent valves
Exclusion Criteria:
* Index ulcer wound that is less than 1 cm in distance from another ulcer wound
* \> 5 ulcers on the index leg
* Index ulcer wound has exposed tendons, ligaments, muscle, or bone
* Index ulcer wound presents with clinical signs of acute infection, suspected or known
* Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
* Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the study limb
* Subjects with active malignancy on the study limb except non-melanoma skin cancer
* Index ulcer that is of arterial disease etiology
* Index ulcer of other primary etiology (ie. vasculitis, arterial, pyoderma)
* Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study treatment phase
* Subjects with planned surgical procedure during the study treatment phase for the index wound including skin flap or skin graft
* Subjects within 6 weeks postoperatively of a vascular o skin graft procedure.
* Subject has had prior skin replacement, negative pressure therapy, or traditional ultrasound therapy applied to the index wound in the 14 days prior to screening
* Subject has had ultrasound treatment (including MIST Therapy) of the index wound.
* Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
* Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
* Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
* Subject has one or more medical condition(s), uncontrolled diabetes (i.e. HbA1c \> 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate
* Subject's wound would require ultrasound near an electronic implant or prosthesis
* Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
* Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01549860
Study Brief:
Protocol Section:
NCT01549860