Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT02445235
Status:
TERMINATED
Last Update Posted:
2016-01-20
First Post:
2015-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor discretion determined no clinical benefit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2015-05-14', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Baseline PRO and Health Status Perception', 'timeFrame': 'Up to eighteen (18) months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'wound care', 'fungal infections', 'scars', 'chronic pain', 'outcomes', 'PRO'], 'conditions': ['Chronic Pain', 'Fungal Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPatients are enrolled for 18 months. The investigator will complete a global patient assessment monthly of the patient's condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Must be receiving therapy for pain, wound care or scar therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An 18 to 85 years old (inclusive) female or male patient\n2. Prescribed compound for the treatment of pain, wound healing or surface skin scar by their Principal Investigator\n3. Any systemic disease (cardiac, renal, or hepatic) must be well controlled.\n4. Has no skin lesions at the site of application of study medication except for wound under treatment\n5. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Pregnant or lactating females or women at the child bearing potential not using effective contraception.\n2. 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.\n3. Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.\n4. 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\n5. 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.'}, 'identificationModule': {'nctId': 'NCT02445235', 'acronym': 'SOPWS', 'briefTitle': 'Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracane Company'}, 'officialTitle': 'Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy', 'orgStudyIdInfo': {'id': 'IFG2015-SOPWS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient Reported Outcome Survey Tool', 'type': 'OTHER', 'description': 'Patient Reported Outcome Survey Tool'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KY', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'BG Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '37862', 'city': 'Sevierville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sevierville Foot and Ankle Clinic', 'geoPoint': {'lat': 35.86815, 'lon': -83.56184}}, {'zip': '76110', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Associates of Internal Medicine', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Pamela Nelson, RN, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracane Company'}, {'name': 'Matt Fruge, BS', 'role': 'STUDY_CHAIR', 'affiliation': 'IFG Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracane Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IFG Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}