Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy

NCT ID: NCT02445235

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

Detailed Description

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This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

Patients are enrolled for 18 months. The investigator will complete a global patient assessment monthly of the patient's condition.

Conditions

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Chronic Pain Fungal Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Patient Reported Outcome Survey Tool

Patient Reported Outcome Survey Tool

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. An 18 to 85 years old (inclusive) female or male patient
2. Prescribed compound for the treatment of pain, wound healing or surface skin scar by their Principal Investigator
3. Any systemic disease (cardiac, renal, or hepatic) must be well controlled.
4. Has no skin lesions at the site of application of study medication except for wound under treatment
5. Able to provide informed consent

Exclusion Criteria

1. Pregnant or lactating females or women at the child bearing potential not using effective contraception.
2. Use of other topical or transdermal medication. Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
3. Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
4. Prior reconstruction skin surgery or skin grafts in the area of cream application preventing absorption of cream except for the treatment of surface skin scar
5. Chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer, or gouty arthritis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IFG Medical

INDUSTRY

Sponsor Role collaborator

Bracane Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Nelson, RN, MS

Role: STUDY_DIRECTOR

Bracane Company

Matt Fruge, BS

Role: STUDY_CHAIR

IFG Medical

Locations

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BG Research

Lexington, Kentucky, United States

Site Status

Sevierville Foot and Ankle Clinic

Sevierville, Tennessee, United States

Site Status

Associates of Internal Medicine

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IFG2015-SOPWS

Identifier Type: -

Identifier Source: org_study_id

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