Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00368602
Status:
TERMINATED
Last Update Posted:
2015-04-07
First Post:
2006-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta Blocker for Chronic Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013999', 'term': 'Timolol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2006-08-24', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': '100% re-epithelialization will be clinically determined at each visit by the Investigator.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcer', 'Burns']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical/index.html', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).', 'detailedDescription': 'The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.\n\nYou will:\n\n* be interviewed and examined\n* have a physical exam\n* have blood and urine tested\n* have photographs taken of the wound\n* apply medication to the leg ulcer as directed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any race btwn 18 and 85 years of age, inclusive;\n* Male or female, neither pregnant nor lactating.\n* Informed consent;\n* Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):\n\n 1. Surface area of ≥2 sq. cm. to ≤20 sq. cm.; Ulcer with largest surface area meeting inclusion criteria will be selected.\n 2. If 2 ulcers present with the same surface area, ulcer of longest duration selected.\n 3. Study ulcer must be at least 2 cm from any other ulcer on same extremity.\n 4. A viable wound bed free of necrotic tissue post-debridement, if debridement is indicated.\n\n 5\\. Have an Ankle Brachial Index (ABI) \\>0.7; 6. Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity; 7. Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study; 8. Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization; 9. Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;\n\n Exclusion Criteria:\n* Decrease in wound surface area of \\>35% btwn Screening and Visit 1 (Randomization);\n* Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;\n* Grade IV ulcer;\n* Evidence of study ulcer infection;\n* Study ulcer of non-venous etiology;\n* Acquired or are known to be infected with HIV;\n* Uncontrolled diabetes mellitus;\n* Immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal;\n* Severe protein malnutrition as defined by serum albumin \\<2.5 g/dL;\n* Severe anemia defined as a total of hemoglobin of \\<10 g/dL for males or \\<8 g/dL for females;\n* Chronic renal insufficiency requiring dialysis;\n* Serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal;\n* New York Heart Association Functional Classification of IV;\n* Deep vein thrombosis (DVT) w/in last 6 weeks or clinical evidence of current DVT;\n* Arterial revascularization of the study extremity w/in previous 6 months from the date of Screening Visit;\n* History, w/in previous 12 months from date of Screen Visit, of alcohol or drug abuse, particularly methadone or heroin;\n* Received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active cellular or acellular product(s) at the site of the study ulcer, investigational drug or device\n* Received previous treatment with systemic corticosteroids prior to Screening (Chronic corticosteroids w/in 90 days or short course corticosteroids w/in 30 days)\n* Been hospitalized for treatment of any venous ulcer w/in the previous 30 days from Screening.\n* Asthma or a history of asthma, obstructive pulmonary disease, myasthenia gravis, hyperthyroidism, history of heart block'}, 'identificationModule': {'nctId': 'NCT00368602', 'briefTitle': 'Beta Blocker for Chronic Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Beta Adrenergic Receptor Modulation of Burn Wound Healing', 'orgStudyIdInfo': {'id': '05-06-00351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.', 'interventionNames': ['Drug: Timoptic']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'The group will be given standard of care with placebo medication.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Timoptic', 'type': 'DRUG', 'otherNames': ['beta adrenergic antagonists'], 'description': 'Timoptic to be applied to the target wound daily for up to 12 weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95655', 'city': 'Mather', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}], 'overallOfficials': [{'name': 'Rivkah R Isseroff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}