Study to Evaluate Outcomes of Patients Receiving Treatmen... | NCT02445235

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

NCT02445235

Sponsor

Bracane Company

Status

Terminated

Last Update Posted

Jan 20, 2016Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Chronic Pain
Fungal Infection

Interventions

Patient Reported Outcome Survey Tool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor discretion determined no clinical benefit

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 8, 2015

First Submission Date that Met QC Criteria

May 14, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2016

Last Update Posted Date

Jan 20, 2016Estimated

Name	Class
IFG Medical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Name	Type	Description	Arm Group Labels	Other Names
Patient Reported Outcome Survey Tool	Other	Patient Reported Outcome Survey Tool

Measure	Description	Time Frame
Change in Baseline PRO and Health Status Perception		Up to eighteen (18) months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pamela Nelson, RN, MS	Bracane Company	Study Director
Matt Fruge, BS	IFG Medical	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BG Research		Lexington	Kentucky	KY	United States
Sevierville Foot and Ankle Clinic

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D009181	Mycoses
D010146	Pain
D002921	Cicatrix

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided