[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646771":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetic with Foot Ulcer","EXPERIMENTAL","Type 2 diabetes mellitus with a non-healing (\\> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment",[13],"Drug: Placenta Stem Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Placenta Stem Cells","Injection of 30 M placenta stem cells into\u002Faround the diabetic foot ulcer and along the anterior and posterior tibial arteries of the index leg.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lucian G. Vlad, MD","Atrium Health Wake Forest Baptist","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Mary-Clare Day, RN","CONTACT","336-713-1343","maryclare.day@advocatehealth.org",[33],{"facility":24,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Winston-Salem","North Carolina","27157","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-80.24422,36.09986,{"lat":43,"lon":42},[46],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100646771","phase-1-placental-cells-for-diabetic-foot-ulcers-100646771",false,"NCT07686094","Placental Cells for Diabetic Foot Ulcers","Phase 1 Safety Trial of Placental Stem Cells (PLSC) to Accelerate the Healing of Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year\n* Unilateral non-healing Diabetic Foot Ulcer (DFU) \\> 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and\u002For compression wrap)\n* No new diabetes medication for at least 2 weeks pre-treatment\n* Subjects must be willing to avoid steroids for the week prior to procedure day\n\nExclusion Criteria:\n\n* Clinical signs of active infection requiring systemic antibiotic therapy less than 7 days prior to enrollment.\n* Radiographic or clinical evidence of active and untreated osteomyelitis at the target ulcer site. Current use of systemic immunosuppressive therapy, including chronic corticosteroids (equivalent to \\>10 mg\u002Fday prednisone for \\>14 days).\n* Hemoglobin (Hgb) A1C \\>12.0 at screening or time in range for the blood glucose level (TIR) less than 30%. Hb A1c should not be used for patient with hypoalbuminemia or anemia in the past 3 months and for patients with Chronic Kidney disease stage 4. For patients who have Continuous Glucose Monitor (CGM), instead of Hb A1c, TIR (time in range) less than 30 % will be used.\n* Patients who are unable \u002F unwilling to tolerate an effective offloading approach. This includes total contact cast, soft felted cast or knee high fracture boot.\n* Current alcohol or substance abuse that, in the opinion of the investigators, would interfere with study participation.\n* Active malignancy or malignancy related limb amputation.\n* Women that are pregnant or planning to become pregnant during the study.\n* Patients with albumin levels less than 3.5 or prealbumin levels less than 18.\n* Subjects with any conditions that the clinical Investigator believes may jeopardize the safety of the patient to participate in the trial.\n* Severe peripheral arterial disease (PAD) (Ankle-Brachial Index (ABI) less than 0.5) or TCOM (Transcutaneous Oximetry Measurement) less than 40 mmHg.\n* TWSB \\> 30 cm2 (total wound surface burden)","ALL","18 Years",{"count":59,"type":60},12,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.",[66],"Diabetic Foot Ulcer",[68,69,70],"diabetic peripheral neuropathy","diabetic foot","placenta stem cells","NOT_YET_RECRUITING","2026-06-30",{"date":74,"type":75},"2026-07-07","ACTUAL",{"date":77,"type":60},"2026-10",{"date":79,"type":60},"2028-12",{"name":5,"class":6},1]