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

NCT01753778 | Completed

• 1 other identifier: MYO-0614
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Entrapment Neuropathy

Keywords

Nerve Entrapment, Morton's neuroma, entrapment neuropathy

Outcome Measures

Primary Outcomes (1)

• Improvement of forefoot pain at day 7

  Improvement of forefoot pain due to nerve entrapment, as measured on the Visual Analog Scale (VAS) for pain at Day 7 as compared to baseline (Day 0).

  7 days

Secondary Outcomes (2)

• Duration of Treatment

  56 days

• Safety Endpoints

  56 days

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with Cryo-Touch III Device at Day 0

Device: Cryo-Touch III Device

Interventions

Cryo-Touch III Device DEVICE

Treatment with Cryo-Touch III

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (2)

SOAR Medical Group

Redwood City, California, 94063, United States

Location

International Clinical Research

Overland Park, Kansas, 66210, United States

Location

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Morton Neuroma

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research

  PRINCIPAL INVESTIGATOR

• Jonah Mullens, DPM

  SOAR Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 20, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (2)