Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

Completed · Not applicable

Conditions studied: Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer

In brief

This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.

Key facts

Study ID

NCT01549860

Run by

Celleration, Inc.

People needed

156

Starts

2012-04-01

Expected to finish

2015-04-01

Last updated by the study team

2015-07-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Shore Hospital — Weymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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