[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-stasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-stasis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,95,121,155,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641858","early-vs-late-tourniquet-release-and-phlebotomy-induced-hemolysis-in-the-emergency-department-tourni-ed-100641858",false,"NCT07617103","Early vs. Late Tourniquet Release and Phlebotomy-Induced Hemolysis in the Emergency Department: TOURNI-ED","Early Versus Late Release of Sphygmomanometer-Applied Venous Stasis and Phlebotomy-Induced Hemolysis in the Emergency Department: A Parallel-Group Randomized Controlled Trial","TOURNI-ED","Inclusion Criteria:\n\n* Age 18 years or older\n* Presenting to the emergency department and triaged as green (semi-urgent) or yellow (urgent) category according to the Emergency Severity Index (ESI) or equivalent institutional triage system\n* Blood collection (venipuncture) indicated as part of routine clinical care by the attending emergency physician\n* Ability to provide written informed consent\n* Accessible antecubital or forearm vein suitable for standard venipuncture (not requiring intravenous catheter placement for blood collection)\n\nExclusion Criteria:\n\n* Blood collection performed via an existing intravenous catheter or central venous access device\n* Known or suspected coagulation disorder (e.g., hemophilia, thrombocytopenia with platelet count \\\u003C50,000\u002FuL, current anticoagulant therapy with active bleeding)\n* Active upper extremity injury, infection, lymphedema, or arteriovenous fistula at the potential collection site\n* Triage category red (resuscitation) at the time of blood collection\n* Declined informed consent\n* Previously enrolled in this study (re-enrollment not permitted)\n* Pregnancy (due to potential vascular changes affecting hemolysis rate)\n* Known hemolytic anemia or other hematological condition associated with baseline elevated hemolysis","ALL","18 Years",{"count":20,"type":21},792,"ESTIMATED","INTERVENTIONAL",[24],"NA","BACKGROUND:\n\nHemolysis is the most common preanalytical error in emergency department (ED) laboratories, affecting 17-26% of blood samples collected in the ED and leading to test cancellations, repeat venipuncture, delayed diagnoses, and increased healthcare costs. Venous stasis created by tourniquet application during phlebotomy is a recognized contributing factor to hemolysis. While clinical guidelines recommend releasing the tourniquet once blood flow is established, the optimal timing of tourniquet release in relation to tube filling sequence has not been systematically evaluated.\n\nOBJECTIVE:\n\nThe primary objective of this trial is to determine whether early release of sphygmomanometer-applied venous stasis (released after the first tube fills) reduces hemolysis rates compared to late release (released after the last tube fills) during routine phlebotomy in ED patients triaged as green or yellow category.\n\nDESIGN:\n\nSingle-center, parallel-group, superiority randomized controlled trial with 1:1 allocation ratio. The trial was prospectively registered prior to the enrollment of the first participant.\n\nPARTICIPANTS:\n\nAdult patients (≥18 years) presenting to the emergency department with triage category green (semi-urgent) or yellow (urgent), for whom blood collection is indicated as part of routine clinical care. Patients requiring blood collection from an intravenous catheter, those with known coagulation disorders, and those who decline to participate are excluded.\n\nINTERVENTIONS:\n\nGroup A (Early Release): Sphygmomanometer inflated to 60 mmHg for venous stasis; tourniquet released immediately after the first tube (sodium citrate, blue cap) completes filling. Remaining tubes (SST\u002Fgel, yellow cap; K2-EDTA, purple cap) are collected after release.\n\nGroup B (Late Release): Sphygmomanometer inflated to 60 mmHg; tourniquet maintained throughout all tube filling and released only after the last tube (K2-EDTA, purple cap) completes filling. Tube collection order follows the CLSI H03-A6 standard for both groups.\n\nPRIMARY OUTCOME:\n\nHemolysis rate, defined as the proportion of serum separator tube (SST\u002Fyellow cap) samples with a Hemolysis Index (HI) ≥ 1+ (corresponding to free hemoglobin ≥50 mg\u002FdL), is assessed by the clinical chemistry laboratory analyzer. The outcome assessor (laboratory technician) is blinded to group assignment.\n\nSECONDARY OUTCOMES:\n\n(1) Distribution of ordinal hemolysis index categories (-, 1+, 2+, 3+, 4+, 5+) in SST samples; (2) Proportion of hemolyzed samples requiring repeat blood collection; (3) Total blood collection duration (seconds) from sphygmomanometer inflation to last tube filling completion; (4) Complication rate (hematoma, nerve injury, vasovagal reaction, arterial puncture, multiple puncture attempts).\n\nSAMPLE SIZE:\n\nA total of 792 participants (396 per group) are required based on an assumed hemolysis rate of 12% in the late release group and 6% in the early release group (50% relative risk reduction), α=0.05 (two-tailed), 80% power (Fleiss with pooled variance), plus 10% dropout buffer.\n\nRANDOMIZATION:\n\nSimple randomization using a computer-generated random number list (randomizer.org). The allocation sequence is maintained by a designated person not involved in enrollment or data collection. Allocation is revealed sequentially at the point of care.\n\nSTATISTICAL ANALYSIS:\n\nPrimary analysis: Chi-square test comparing hemolysis rates between groups (intention-to-treat population). Secondary analyses: Mann-Whitney U test for ordinal HI distribution; logistic regression for adjusted odds ratio. Bonferroni correction applied to multiple secondary comparisons (adjusted α = 0.017). Per-protocol analysis performed as a sensitivity analysis. Missing data handled using complete case analysis with sensitivity analysis.",[27,28,29,30],"Hemolysis","Blood Specimen Collection","Phlebotomy","Venous Stasis",[32,33,34,35,36,37,38,39],"hemolysis","phlebotomy","tourniquet","venous stasis","emergency department","blood collection","hemolysis index","randomized controlled trial","NOT_YET_RECRUITING","2026-06-13",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":21},"2026-06",{"date":48,"type":21},"2027-08",{"name":50,"class":51},"Marmara University Pendik Training and Research Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355","NCT07538609","The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study","Preoperative Inclusion Criteria:\n\n* Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator\u002Fsub-investigator.\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent themself.\n\nIntraoperative Inclusion Criteria:\n\n* Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow\u002Foutflow to\u002Ffrom the target lesion(s), per investigator\u002Fsub- investigator discretion.\n* Lesion can be traversed with a guidewire.\n\nIntraoperative Exclusion Criteria:\n\n* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.",{"count":60,"type":21},150,[24],"This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[64,65,66,30,67,68,69,70],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[72,73,74,68,75,76,77,78,79,80,65,81,82,83,84],"Vein Stent","VIAFORT","Venous Thrombosis","Gore","Venous occlusion","VIABAHN FORTEGRA","FORTEGRA","Deep Venous Insufficiency","Deep venous","DVT Treatment","Venous Stent","Venous insufficiency treatment options","Venous disease treatment options","2026-05-11",{"date":87,"type":44},"2026-05-14",{"date":89,"type":21},"2026-10-07",{"date":91,"type":21},"2031-05",{"name":93,"class":94},"W.L.Gore & Associates","INDUSTRY",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100476872","the-gore-viabahn-fortegra-venous-stent-iliofemoral-study-100476872","NCT05489588","The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study","Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction","Preoperative Inclusion Criteria:\n\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent.\n* One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.\n* Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.\n* Estimated life expectancy ≥1 year.\n* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.\n\nPreoperative Exclusion Criteria:\n\n* Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.\n* Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.\n* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.\n* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):\n\n  1. uncorrected INR\\>2 (not as a result of warfarin or DOAC therapy), OR\n  2. platelet count \\\u003C50,000 or \\>1,000,000 cells\u002Fmm3, OR\n  3. white blood cell count \\\u003C3,000 or \\>12,500 cells\u002Fmm3\n* Patient has impaired renal function (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or is currently on dialysis.\n* Patient has uncorrected hemoglobin of \\\u003C9 g\u002FdL.\n* Patient has known history of antiphospholipid syndrome (APS).\n* Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.\n* Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index procedure.\n* Patient has had or requires open deep venous surgery in the target limb.\n* Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator\u002Fsub-investigator. Observational studies are permitted.\n* Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.\n* Patient has known sensitivity to device materials.\n* Patient has had prior stenting or grafts in the target vessels.\n* Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that can be managed, and with an active clinical plan in place may be eligible.\n* Patient has known history of intravenous drug abuse within one year of treatment.\n* Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).\n* Patient has a BMI \\>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.\n* Patient is actively undergoing or plans to begin cancer treatment.\n* Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.\n* Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).\n\nIntraoperative Inclusion Criteria:\n\n* Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and\u002For common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.\n* Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Lesion can be traversed with a guidewire.\n* Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.\n* Patient does not have significant (i.e., \\>20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.",{"count":103,"type":21},165,[24],"This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.",[64,65,66,30,67,68,69,70,107,108],"Vein Occlusion","Vein Disease",[73,72,74,68,75,69,78,77,65,79,110,80,81,82,83],"Venous disease treatment Options","RECRUITING","2026-04-07",{"date":114,"type":44},"2026-04-09",{"date":116,"type":44},"2023-03-02",{"date":118,"type":21},"2031-03",{"name":93,"class":94},27,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":140,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100570426","phase-3-tissue-repair-gel-in-venous-leg-ulcers-us-100570426","NCT06707090","Tissue Repair Gel in Venous Leg Ulcers (US)","A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)","TRIVIA","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* Participants considered nutritionally deficient.",{"count":130,"type":21},312,[132],"PHASE3","The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.",[66,67,135,30,136,137,138,139],"Venous Stasis Ulcer","Wound Heal","Wounds","Venous Insufficiency of Leg","Non-healing Wound",[141,142,143,144,145],"Tissue Repair","Glucoprime","TR Therapeutics","Debridement","VLU","2026-02-09",{"date":148,"type":44},"2026-02-12",{"date":150,"type":44},"2025-01-28",{"date":152,"type":21},"2028-02",{"name":143,"class":94},33,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100578485","non-healing-venous-leg-ulcers-treated-with-standard-care-with-or-without-br-ac-100578485","NCT06811909","Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC","A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC","Inclusion Criteria:\n\n1. Patient has signed the informed consent form.\n2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.\n3. Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.\n\n   1. If the subject presents with \\> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.\n   2. If the target ulcer is \\\u003C 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.\n4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.\n5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).\n6. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.\n\n   a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.\n7. Arterial supply adequacy confirmed by any one of the following:\n\n   1. Great toe pressure ≥ 50 mm\u002FHg\n   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10\n   3. TcPO2 ≥ 40 mmHg from the foot\n8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.\n\nExclusion Criteria:\n\n1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).\n2. Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.\n3. Clinical evidence of ulcer bed infection, or infected hardware.\n4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.\n5. Refusal or inability to tolerate compression therapy.\n6. Pregnant women.\n7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.\n8. Hemoglobin A1c (HbA1c) level is \\> 12% (108 mmol\u002Fmol).\n9. Current therapy with systemic antibiotics.\n10. Current therapy with cytotoxic agents.\n11. Current therapy with chronic (\\> 10 days) oral corticosteroids.\n12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).\n13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).\n14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.\n15. Currently on dialysis or planning to start dialysis.\n16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.\n17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.\n18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.\n19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.",{"count":163,"type":21},60,[24],"This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.\n\nThis study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.",[167,66,168,30,169],"Non-infected Venous Leg Ulcer","Venous Insufficiency","Venous Reflux","2026-01-21",{"date":172,"type":44},"2026-01-23",{"date":174,"type":44},"2025-02-14",{"date":176,"type":21},"2026-10",{"name":178,"class":94},"BioStem Technologies",23,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":126,"acronym":127,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":133,"conditions":188,"keywords":190,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100570427","phase-3-tissue-repair-gel-in-venous-leg-ulcers-in-auus-100570427","NCT06707103","Tissue Repair Gel in Venous Leg Ulcers in AU\u002FUS","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* History of cancer in the preceding 5 years (except as noted in the protocol).\n* Participants considered nutritionally deficient.",{"count":130,"type":21},[132],[66,67,135,30,136,189,138,139],"Wound",[141,142,143,144,145],"2025-03-27",{"date":193,"type":44},"2025-04-02",{"date":195,"type":21},"2025-04",{"date":197,"type":21},"2027-02",{"name":143,"class":94},12]