[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Estar Medical dba Medical Technologies, LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100617451","phase-2-using-tropocellsr-autologous-platelet-rich-fibrin-prf-to-treat-chronic-non-healing-wounds-100617451",false,"NCT07318792","Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds","Evaluation of the Safety and the Clinical Effectiveness of Using Tropocells® Autologous PRF System to Treat Chronic, Non-healing, Non-infected Wounds in Combination With Standard of Care (SOC).","Inclusion Criteria:\n\n* 1\\. Male or female ≥ 18≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided.\n\n  3\\. Located in any anatomical location on the body. 4. If more than one non-healing wound is present, an index wound will be selected ≥ 1.0 cm2 size and less than or equal to 25.0 cm2.\n\n  5\\. If the wound is in an ulcer cluster the dominant ulcer will be selected, with at least 2.0 cm2 between the index wound and other wounds.\n\n  6\\. The study wound will be present for at least thirty (30) days and the subject will have undergone standard of care assessment and intervention, according to the wound type being evaluated, where SOC may include, but not be limited to, proper cleansing and debridement, off-loading, compression, bioburden reduction, moisture management, infection control, optimized perfusion, venous ablation, nutrition supplementation, smoking cessation counseling and medical therapy, and access to wound and underlying disease education and training.\n\n  7\\. Neurovascular assessment, conducted according to the assessment typically performed for the wound type will be performed during Screening (Study Visit 1), and repeated at the level normally conducted at the follow-up visits. Perfusion should be adequate to sustain a healing process. Neurological examinations will be performed to document the presence of neuropathy and\u002For nerve injury.\n\n  8\\. Documented 40% or less wound closure during thirty (30) days of standard of care (SOC).\n\n  9\\. No clinical signs of infection at the wound site or the affected limb. 10. Post-debridement with no residual necrotic tissue. 11. Platelet counts should be within normal range ≥ 105,000 to \\\u003C450, 000. 12. Hemoglobin (Hgb) ≥ 10 g\u002FdL and Hematocrit (HCT) ≥ 27%. 13. HbA1C ≤ 12%. 14. Chronic renal failure (CRF) and dialysis patients may be enrolled. 15. PT\u002FaPTT\u002FINR should be within normal limits unless the subject is on coumadin, then maintain range of INR 2 to 3.\n\n  16\\. Prealbumin ≥ 15 mg\u002FdL. 17. Adequate off-loading of the wound site for wheelchair bound, bed bound, and ambulatory subjects.\n\n  18\\. Multi-layered compression dressings for venous related wounds. 19. Females of childbearing potential should not be pregnant and agree to avoid conceiving during the study.\n\n  20\\. Males agree to use contraception or abstinence during the study. 21. The subject has provided written informed consent prior to any screening procedures and agrees to comply with study procedures and requirements.\n\n  22\\. Usual care therapies that may be included will be negative pressure wound therapy (NPWT), antimicrobial dressings, collagen containing matrix and packing materials.\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\n  1. Life expectancy is less than twelve (12) months.\n  2. Participation in another clinical trial involving an investigational device or drug within thirty (30) days prior to enrollment.\n  3. Sepsis within two (2) weeks prior to enrollment.\n  4. Soft tissue infection affecting the wound within two (2) weeks prior to enrollment.\n  5. Known osteomyelitis or occult osteomyelitis documented with inflammatory markers ESR ≥ 60 and\u002For CRP ≥7.9 mg\u002FdL.\n  6. Religious constraints to using blood products, including autologous blood.\n  7. Alcohol or substance abuse (other than tobacco) within 2 months prior.\n  8. Severe lymphedema at Stage 3b or greater (lymphostatic elephantiasis).\n  9. The inability to use compression therapy for venous insufficiency or lymphedema.\n  10. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.\n  11. Hemophilia, sickle cell anemia, thrombocytopenia, and leukemia or blood dyscrasia.\n  12. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin, intravenously. However, subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.\n  13. Cytostatic therapy within the past 12 months.\n  14. The subject has inadequate venous access for repeated blood draw.\n  15. Known HBV, HCV, or HIV.\n  16. Blood-borne or communicable disease that would likely prevent full participation in the trial (HIV, AIDS, COVID-19).\n  17. Subjects with known sensitivity to blood components of the PRF Kit (e.g., rubber stopper, vacutainer tubing).\n  18. Advanced therapy treatments with hyperbaric oxygen, electrical stimulation (eStim), pulsed electromagnetic energy fields (PEMF), colored light therapies, cellular tissue products (CTPs) like amniotic tissues, Apligraf® and Dermagraft® will be excluded; while NPWT, collagen matrix products (sheet or bulk packing), antimicrobial dressings (surfactants, silver or copper, hypochlorous acid) may be used.\n\nAIDS- acquired immunodeficiency syndrome; COPD-chronic obstructive pulmonary disease; COVID-19- Coronavirus Disease-19; CRP- C-reactive protein; ESR-erythrocyte sedimentation rate; HBV-hepatitis B virus; HCV- hepatitis C virus; HIV- human immune-deficiency virus.","ALL","18 Years","80 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.",[27,28],"Wound Chronic Draining","Wound Closure",[30,31,32,33],"Chronic Non-healing Wounds","TropoCells(R) Platelet-rich Fibrin (PRF)","Autologous Platelet-rich Fibrin (PRF)","Platelet Derived Therapy","NOT_YET_RECRUITING","2026-01-04",{"date":37,"type":38},"2026-01-06","ACTUAL",{"date":40,"type":21},"2026-01-01",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"Estar Medical dba Medical Technologies, LTD","INDUSTRY",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100578394","phase-2-evaluate-use-of-tropocellsr-autologous-platelet-rich-fibrin-prf-for-wagner-grade-1-and-grade-2-mild-to-mod-neuroischemic-plantar-diabetic-foot-ulcer-wound-care-100578394","NCT06810726","Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.","EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age\n2. Type 1 or Type 2 Diabetes\n3. Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day\n4. Ulcer Size 1.0 cm2 to 12.0 cm2\n5. Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm\n6. If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.\n7. At least 2.0 cm between the index wound and other wounds.\n8. Study ulcer has been present for at least 30 days and has undergone the 14-day\n9. Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.\n10. WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)\n11. Screening Period of the standard of care with 20% or less wound closure.\n12. No Clinical Signs of Infection at the wound site or the affected limb.\n13. Post-debridement without signs of necrotic tissue.\n14. Normal Platelet count ≥ 105,000 and \\\u003C450, 000 (according to CBC)\n15. Hemoglobin (Hgb) ≥10 g\u002FdL and Hematocrit (HCT) ≥ 27% (according to CBC)\n16. Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist\n17. No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15\n18. PT\u002FPTT - INR between 2.0-3.0 (with blood thinners).\n19. Nutritional Status with no severe protein deficiency, Pre-albumen \\>15 mg\u002FdL\n20. Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).\n21. If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.\n22. Male subjects agree to use contraception or abstinence during the trial.\n23. The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.\n\nExclusion Criteria:\n\n1. Life expectancy is less than 12 months.\n2. Anemia Hgb ≤ 10 g\u002FdL and HCT ≤ 27%.\n3. Ulcers of other than diabetic foot pathophysiology.\n4. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.\n5. Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.\n6. Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.\n7. Osteomyelitis at the designated wound site; using ESR ≥ and \u002For CRP ≥ 7.9 mg\u002Fd as a screen.\n8. CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.\n9. Religious constraints to using blood products, including autologous blood.\n10. Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.\n11. Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).\n12. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.\n13. The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.\n14. The subject is undergoing hemodialysis.\n15. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.\n16. Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.\n17. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.\n18. Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.\n19. Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.\n20. Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.\n21. Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.\n22. Received radiation therapy or chemotherapy within the previous 3 months.\n23. Subjects with known sensitivity to blood components such as those in the PRF kit.\n24. The subject has inadequate venous access for repeated blood draws required for the PRP preparation.",{"count":55,"type":21},30,[24],"The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nMeasure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group.\n\nRun-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care.\n\nActive Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System.\n\nFollow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.",[59,60,61,62,63,64],"Diabetic Foot Ulcer","Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus (T2DM)","Neuroischemic Foot Ulcer","Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)","Chronic Wound Care",[66,67,68,69,64],"PRF used for Wagner Grade 2 DFU","Tropocells Platelet-rich Fibrin","Platelet-rich Plasma (PRP)","Platelet-derived Factors for wound care","RECRUITING","2025-06-10",{"date":73,"type":38},"2025-06-12",{"date":75,"type":38},"2025-04-15",{"date":77,"type":21},"2026-08-15",{"name":44,"class":45},""]