Study Evaluating Treatment of Forefoot Pain Related to Nerve Entrapment Using the Cryo-Touch III Device

Completed · Not applicable

Conditions studied: Entrapment Neuropathy

In brief

A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III Device for temporary relief of pain.

Key facts

Study ID

NCT01753778

Run by

Pacira Pharmaceuticals, Inc

People needed

7

Starts

2012-11-01

Expected to finish

2013-08-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years of age and older. Female subjects of childbearing potential must not be pregnant at time of treatment.
• Trial participants must have a confirmed diagnosis of pain in the forefoot that is due to entrapment of related nerves.
• Any medication must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed.
• Must have an average score for pain of ≥ 4/10 Visual Analog Scale (VAS) over the last 7 days.
• Subject is willing and able to give written informed consent and able to comply with study instructions.
• Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
• Subject is in otherwise good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

You may not qualify if…

• History of fibromyalgia, cerebrovascular accident (CVA), foot or lower limb trauma, stroke, or bone deformity.
• Patient who has severe pain for any reason other than forefoot pain due to nerve entrapment.
• Any additional diagnosis that in the opinion of the investigator directly contributes to forefoot pain.
• Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)
• Surgical invention previously conducted in the forefoot area.
• Any injection (neurolytic, sclerosing, anesthetic, etc.) to the foot within the last 2 months.
• Any use of systemic injections (in any area) for pain management within the last 4 months.
• Any use (i.e. oral, topical, inhaled and/or injected) of anesthetics or steroids within the last 30 days.
• Current enrollment in an investigational drug or a device study that specifically targets pain treatment.
• Enrollment in any other investigational drug or device study or participation within the last 30 days.
• Any clotting disorder and/or use of any anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the treatment.
• Allergy or intolerance to any preparatory treatment agent or any other substance utilized within the study.
• Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment, outcomes, or subject safety.
• Any confounding diagnosis or medical condition that in the investigator's opinion would adversely affect study participation or subject safety.
• Any chronic medication use (prescription, over-the-counter, supplements, etc.) that in the investigator's opinion would adversely affect study participation or subject safety.
• Any reason that, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related foot injury due to a worker's compensation claim, etc.).

Where it is running

• SOAR Medical Group — Redwood City, California, United States
• International Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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