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

Chronic Pain Clinical Trial

— SOPWS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02445235
• Other study ID #: IFG2015-SOPWS
• Status: Terminated
• Phase: N/A
• First received: May 8, 2015
• Last updated: January 18, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bracane Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Fungal Infection
• Mycoses

Intervention

Other:
• Patient Reported Outcome Survey Tool
Patient Reported Outcome Survey Tool

Locations

Country	Name	City	State
United States	Associates of Internal Medicine	Fort Worth	Texas
United States	BG Research	Lexington	Kentucky
United States	Sevierville Foot and Ankle Clinic	Sevierville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Bracane Company	IFG Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline PRO and Health Status Perception		Up to eighteen (18) months	No