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

An observational study of Chronic Pain and Fungal Infection, run by Bracane Company at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Chronic Pain, Fungal Infection
What is being tested?: Patient Reported Outcome Survey Tool
How many people: 88 participants
Where: 3 sitesUnited States
Study dates: Apr 2015to Jan 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Must be receiving therapy for pain, wound care or scar therapy

Who may be able to join

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

Who cannot join

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 Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Associates of Internal Medicine
Fort Worth, Texas, 76110
BG Research
Lexington, Kentucky, KY
Sevierville Foot and Ankle Clinic
Sevierville, Tennessee, 37862

Other trials in United States

About this study

Read the detailed description

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

Conditions: Chronic Pain, Fungal Infection
Being tested: Patient Reported Outcome Survey Tool
Keywords: pain, wound care, fungal infections, scars, chronic pain, outcomes, PRO
Medical subject headings: Chronic Pain, Mycoses, Pain, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient Reported Outcome Survey ToolOther
Patient Reported Outcome Survey Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Baseline PRO and Health Status Perception
Measured: Up to eighteen (18) months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Jan 2016

First posted15 May 2015 (estimated)
Study startApr 2015
Primary completionJan 2016
Study completionJan 2016

Why it stopped: Sponsor discretion determined no clinical benefit

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445235
Sponsor's protocol ID: IFG2015-SOPWS
Acronym: SOPWS
Status last verified: Jan 2016
First submitted: 8 May 2015
Last updated: 20 Jan 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy
ClinicalTrials.gov ID: NCT02445235
Acronym / sponsor ID: SOPWS / IFG2015-SOPWS
Conditions: Chronic Pain, Fungal Infection
Keywords: pain, wound care, fungal infections, scars, chronic pain, outcomes, PRO
Study type: Observational
Recruitment status: TerminatedReason stopped: Sponsor discretion determined no clinical benefit
Enrolment: 88 participants (actual)
Lead sponsor: Bracane CompanyIndustry (pharma, biotech, devices)
Collaborators: IFG Medical
Study start: Apr 2015
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 15 May 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Must be receiving therapy for pain, wound care or scar therapy

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient Reported Outcome Survey ToolPatient Reported Outcome Survey Tool	Other	–

Primary outcome

Change in Baseline PRO and Health Status Perception
Time frame: Up to eighteen (18) months

Results and safety

The study was stopped early (reason given: Sponsor discretion determined no clinical benefit). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
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RecruitingObservational study
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Nelson, RN, MS study director

Bracane Company

Matt Fruge, BS study chair

IFG Medical

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Fungal Infection, run by Bracane Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor discretion determined no clinical benefit). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline PRO and Health Status Perception (time frame: Up to eighteen (18) months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.