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

NCT02445235 | Terminated

• 1 other identifier: IFG2015-SOPWS
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Pain; Fungal Infection

Keywords

pain; wound care; fungal infections; scars; chronic pain; outcomes; PRO

Outcome Measures

Primary Outcomes (1)

• Change in Baseline PRO and Health Status Perception

  Up to eighteen (18) months

Interventions

Patient Reported Outcome Survey Tool OTHER

Patient Reported Outcome Survey Tool

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Must be receiving therapy for pain, wound care or scar therapy

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating females or women at the child bearing potential not using effective contraception.
• 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 Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
• Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
• 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
• 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.

Sponsors & Collaborators

• Bracane Company: lead
• IFG Medical: collaborator

Study Sites (3)

BG Research

Lexington, Kentucky, KY, United States

Location

Sevierville Foot and Ankle Clinic

Sevierville, Tennessee, 37862, United States

Location

Associates of Internal Medicine

Fort Worth, Texas, 76110, United States

Location

MeSH Terms

Conditions

Chronic Pain; Mycoses; Pain; Cicatrix

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections; Fibrosis; Pathologic Processes

Study Officials

• Pamela Nelson, RN, MS

  Bracane Company

  STUDY DIRECTOR

• Matt Fruge, BS

  IFG Medical

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 15, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (3)