- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445235
Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy (SOPWS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, KY
- BG Research
-
-
Tennessee
-
Sevierville, Tennessee, United States, 37862
- Sevierville Foot and Ankle Clinic
-
-
Texas
-
Fort Worth, Texas, United States, 76110
- Associates of Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Baseline PRO and Health Status Perception
Time Frame: Up to eighteen (18) months
|
Up to eighteen (18) months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Pamela Nelson, RN, MS, Bracane Company
- Study Chair: Matt Fruge, BS, IFG Medical
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFG2015-SOPWS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Washington University School of MedicineCompletedHip Pain Chronic | Back Pain | Chronic Pain | Knee Pain ChronicUnited States
Clinical Trials on Patient Reported Outcome Survey Tool
-
University of Colorado, DenverNational Cancer Institute (NCI)RecruitingBreast CancerUnited States
-
NYU Langone HealthAgency for Healthcare Research and Quality (AHRQ)Not yet recruiting
-
AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic Purpura
-
Seoul National University HospitalSK Telecom ConsortiumCompleted
-
RoCompletedErectile Dysfunction | Telemedicine | Internet-based Intervention | Online Intervention | Web-based InterventionUnited States
-
Centre Hospitalier National d'Ophtalmologie des...Not yet recruitingAge-Related Macular Degeneration
-
Geisinger ClinicPatient-Centered Outcomes Research Institute; Penn State University; University... and other collaboratorsActive, not recruitingPediatric Obesity | Preventive Medicine | Mentoring | Food SupplyUnited States
-
Radboud University Medical CenterJeroen Bosch ZiekenhuisRecruitingPatient Engagement | Intensive Care Unit SyndromeNetherlands
-
Karolinska InstitutetSkandinaviska Forskningsstiftelsen för Åderbråck och andra VensjukdomarCompletedQuality of Life | Superficial Venous Insufficiency | Change After TreatmentSweden
-
Imam Abdulrahman Bin Faisal UniversityQatif Central HospitalRecruitingAnterior Cruciate Ligament | InjuriesSaudi Arabia