Nctid:
NCT06616844
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000017719", "term"=>"Diabetic Foot"}, {"id"=>"D000016523", "term"=>"Foot Ulcer"}, {"id"=>"D000014456", "term"=>"Ulcer"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000003925", "term"=>"Diabetic Angiopathies"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000007871", "term"=>"Leg Ulcer"}, {"id"=>"D000012883", "term"=>"Skin Ulcer"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000048909", "term"=>"Diabetes Complications"}, {"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000003929", "term"=>"Diabetic Neuropathies"}, {"id"=>"D000005534", "term"=>"Foot Diseases"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M17206", "name"=>"Ulcer", "asFound"=>"Ulcer", "relevance"=>"HIGH"}, {"id"=>"M19933", "name"=>"Diabetic Foot", "asFound"=>"Diabetic Foot", "relevance"=>"HIGH"}, {"id"=>"M18919", "name"=>"Foot Ulcer", "asFound"=>"Foot Ulcer", "relevance"=>"HIGH"}, {"id"=>"M7120", "name"=>"Diabetic Angiopathies", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M10883", "name"=>"Leg Ulcer", "relevance"=>"LOW"}, {"id"=>"M15686", "name"=>"Skin Ulcer", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M26004", "name"=>"Diabetes Complications", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M7124", "name"=>"Diabetic Neuropathies", "relevance"=>"LOW"}, {"id"=>"M8658", "name"=>"Foot Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M5953", "name"=>"Chlorhexidine", "relevance"=>"LOW"}, {"id"=>"M10488", "name"=>"Iodine", "relevance"=>"LOW"}, {"id"=>"M229695", "name"=>"Cadexomer iodine", "relevance"=>"LOW"}, {"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M14088", "name"=>"Povidone-Iodine", "relevance"=>"LOW"}, {"id"=>"M14087", "name"=>"Povidone", "relevance"=>"LOW"}, {"id"=>"M9918", "name"=>"Hydrogen Peroxide", "relevance"=>"LOW"}, {"id"=>"M344731", "name"=>"Chlorhexidine gluconate", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21319", "name"=>"Acetic Acid", "relevance"=>"LOW"}, {"id"=>"M303111", "name"=>"Retinol acetate", "relevance"=>"LOW"}, {"id"=>"M4215", "name"=>"Anti-Infective Agents, Local", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"M1740", "name"=>"Cetrimonium", "relevance"=>"LOW"}, {"id"=>"T436", "name"=>"Acetic Acid", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"Blood Substitutes", "abbrev"=>"BlSubst"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>194}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-02", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 12 weeks.", "timeFrame"=>"12 weeks", "description"=>"Measure the incidence of complete wound closure, defined as 100% reepithelialization of the wound without drainage, confirmed at a second clinical visit occurring at least 2-weeks after the visit where wound closure was initially observed"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Wound Heal", "Ulcer"]}, "descriptionModule"=>{"briefSummary"=>"A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion:\n\n1. Subjects at least 21 years old. At least 50% of the enrolled population must be \\> 65 years of age.\n2. Known history of type 1 or type 2 diabetes.\n3. The patient must have a target ulcer meeting the following characteristics:\n\n i. A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii. Located on the anatomical foot; defined as a minimum of 50% of ulcer area extending distal to the medial malleolus.\n\n iii. The target ulcer must have been present for a minimum of 4 weeks and no longer than 52 weeks.\n\n iv. The target ulcer must display evidence of delayed wound healing, defined as less than 50% wound area reduction over the four weeks preceding randomization.\n\n v. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post-debridement.\n4. If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be:\n\n i. the ulcer with the largest wound area; ii. ≥ 2cm distant from any other ulcer on the affected limb, post-debridement; iii. the only ulcer to be evaluated by the study (one patient, one wound).\n5. Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic.\n6. BMI ≤45\n7. Subject is willing to participate in all procedures and follow-up evaluations necessary to complete the study.\n8. Subject has signed informed consent.\n\nExclusion:\n\n1. The potential subject is known to have a life expectancy of \\<6 months.\n2. Index Ulcers will be excluded if they meet any of the following criteria upon assessment:\n\n i. Index ulcer determined to be due to a condition other than diabetes ii. Active Charcot deformity OR major structural abnormalities of the foot iii. Known or suspected local skin malignancy to the index diabetic ulcer iv. Wound duration \\>12 months without intermittent closure\n3. The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection:\n\n i. erythema that extends ≥ 0.5cm from wound edge ii. local increased warmth iii. purulent exudate iv. local swelling or induration v. local tenderness or pain\n4. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\\'s exam or radiographic evidence.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the target ulcer, as measured by digital planimetry or manual linear measurements (e.g. with a ruler), decreases by more than 25% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period).\n9. The surface area of the target ulcer, as measured by digital planimetry, decreases by more than 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. The potential subject is unable to adhere to therapeutic offloading, if required by anatomical location of target ulce.\n11. Women who are pregnant or considering becoming pregnant within the next 6 months.\n12. The potential subject has end stage renal disease requiring dialysis.\n13. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.\n14. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n15. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n16. The potential subject has a malnutrition indicator score \\<17 as measured on the Mini Nutritional Assessment.\n17. Potential subjects with a sensitivity or allergy to porcine materials or collagen will be excluded.\n18. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials will be excluded.\n19. A subject with a disorder that would create unacceptable risk of treatment complications is excluded.\n20. Subjects will be considered ineligible for enrolment if any of the following criteria are met:\n\n i. Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV.\n\n ii. In the past 6 months, having undergone a revascularization procedure aimed at increasing blood flow in the target limb OR any amputation affecting the target limb"}, "identificationModule"=>{"nctId"=>"NCT06616844", "acronym"=>"IDEAL", "briefTitle"=>"IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"ConvaTec Inc."}, "officialTitle"=>"Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.", "orgStudyIdInfo"=>{"id"=>"WC-24-453"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Standard of Care (SOC)", "description"=>"Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;\n\nWound bed debridement, if clinically indicated.\n\nPrimary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;\n\nA secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;\n\nOff-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,\n\nAppropriate use of systemic antibiotics."}, {"type"=>"EXPERIMENTAL", "label"=>"Standard of Care + Intervention", "description"=>"SOC arm with the following modifications:\n\n* Consecutive weekly application of PPECM for the 12-week study period.\n* Subjects will receive no more than 12 applications of PPECM\n\nNote: PPECM should be applied after standard wound cleansing and debridement procedures, prior to the application of primary wound dressing, in accordance with the IFU.", "interventionNames"=>["Device: InnovaMatrix® AC"]}], "interventions"=>[{"name"=>"InnovaMatrix® AC", "type"=>"DEVICE", "otherNames"=>["Porcine Placental ExtraCellular Matrix (PPECM)"], "description"=>"SOC plus weekly application of the study device", "armGroupLabels"=>["Standard of Care + Intervention"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21742", "city"=>"Hagerstown", "state"=>"Maryland", "country"=>"United States", "contacts"=>[{"name"=>"Kimberley Shrewsbridge", "role"=>"CONTACT", "email"=>"KShewbridge@us-fas.com", "phone"=>"301-531-5290"}, {"name"=>"Brandy Grahn", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"US-FAS", "geoPoint"=>{"lat"=>39.64176, "lon"=>-77.71999}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "contacts"=>[{"name"=>"Connor Roddy", "role"=>"CONTACT", "email"=>"Connor.Roddy@bmc.org", "phone"=>"617-414-6839"}, {"name"=>"Vitaly Volansky", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Boston Medical Center", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"11042", "city"=>"New Hyde Park", "state"=>"New York", "country"=>"United States", "contacts"=>[{"name"=>"Sally Kaplan", "role"=>"CONTACT", "email"=>"skaplan2@northwell.edu", "phone"=>"516-562-4578"}, {"name"=>"Alisha Oropallo", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Northwell Health Comprehensive Wound Healing Center", "geoPoint"=>{"lat"=>40.7351, "lon"=>-73.68791}}, {"zip"=>"27609", "city"=>"Raleigh", "state"=>"North Carolina", "country"=>"United States", "contacts"=>[{"name"=>"Allison Denton", "role"=>"CONTACT", "email"=>"adenton@us-fas.com", "phone"=>"919-213-0261"}, {"name"=>"Alan Boehm", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"US-FAS", "geoPoint"=>{"lat"=>35.7721, "lon"=>-78.63861}}], "centralContacts"=>[{"name"=>"Andrew Thomas", "role"=>"CONTACT", "email"=>"andrew.thomas@convatec.com", "phone"=>"07767036374"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"ConvaTec Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}