[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Skye Biologics Holdings, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,64],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100596479","mri-evaluation-of-graft-maturation-following-acl-reconstruction-100596479",false,"NCT07046000","MRI Evaluation of Graft Maturation Following ACL Reconstruction","Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft","Inclusion Criteria:\n\n* ACL tear and reconstruction; no other knee ligaments needing reconstruction\n* Primary (first-time) ACL tear in the affected knee\n* ACL injury occurred less than 12 months before ACL reconstruction\n* Have no contraindications or allergies to the treatment administered\n* Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses\n* Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue\n* Able and willing to comply with the post-operative study follow-up schedule\n\nExclusion Criteria:\n\n* Prior surgery on the index knee within 12 months of enrollment\n* Steroid injection into the index knee within 6 weeks of enrollment\n* Chronic ACL tear whereas the injury occurred more than 12 months ago\n* Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed\n* Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)\n* Contraindication to MRI (eg, implanted devices incompatible with MRI).\n* Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery\n* History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher\n* History of malignant tumor and osseous metastatic disease,\n* History of chronic pain disorders (i.e., fibromyalgia),\n* Current substance abuse (drug or alcohol), by the investigator's judgment,\n* Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.\n* Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,\n* Currently involved in any injury litigation or workers compensation claims,\n* Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.","ALL","14 Years","50 Years",{"count":20,"type":21},10,"ESTIMATED","OBSERVATIONAL","Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.",[25],"ACL Tears","NOT_YET_RECRUITING","2026-04-23",{"date":29,"type":30},"2026-04-24","ACTUAL",{"date":32,"type":21},"2026-08-01",{"date":34,"type":21},"2028-02",{"name":36,"class":37},"Skye Biologics Holdings, LLC","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":38},"100575070","clinical-trial-evaluating-an-amnion-membrane-allograft-for-use-in-the-management-of-non--healing-diabetic-foot-ulcers-versus-standard-of-care-100575070","NCT06767501","Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care","A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.\n3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.\n7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:\n\n   1. TCOM ≥30 mmHg\n   2. ABI between 0.7 and 1.3\n   3. PVR: Biphasic\n   4. TBI ˃0.6\n   5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle.\n8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.\n10. The subject must consent to using the prescribed off-loading method for the duration of the study.\n11. The subject must agree to attend the weekly study visits required by the protocol.\n12. The subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\\u003C 6 months is excluded.\n2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.\n4. Index ulcer and\u002For index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled\n5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n8. If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he\u002Fshe is excluded.\n9. If a subject has a serum creatinine ≥ 3.0mg\u002FdL within 6 months of randomization he\u002Fshe is excluded.\n10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1\u002Frandomization visit during which time the subject received SOC.\n11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.\n12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n13. A potential subject with end stage renal disease requiring dialysis is excluded.\n14. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n15. Subject treated with hyperbaric oxygen therapy or a Cellular and\u002For Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.","18 Years",{"count":48,"type":21},100,"INTERVENTIONAL",[51],"NA","The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following:\n\n* Rate of wound closure\n* Change in ulcer size over 12 weeks\n* Any adverse events or reactions (side effects)\n* Changes in neuropathy (nerve damage)\n* Change in pain levels\n* Occurrence of infection",[54],"Diabetic Foot Ulcers (DFUs)","RECRUITING","2025-01-08",{"date":58,"type":30},"2025-01-10",{"date":60,"type":30},"2024-12-28",{"date":62,"type":21},"2025-12",{"name":36,"class":37},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":49,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":81,"locationsCount":38},"100574874","clinical-trial-evaluating-an-amnion-membrane-allograft-intended-for-use-in-the-management-of-non--healing-venous-leg-ulcers-versus-standard-of-care-alone-100574874","NCT06764953","Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone","A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n5. The subject must consent to using the prescribed off-loading method for the duration of the study.\n6. The subject must agree to attend the weekly study visits required by the protocol.\n7. The subject must be willing and able to participate in the informed consent process.\n8. The target ulcer must be full thickness on the foot or leg that does not probe to bone.\n9. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:\n\n   1. TCOM ≥30 mmHg\n   2. ABI between 0.7 and 1.3\n   3. PVR: Biphasic\n   4. TBI ˃0.6\n   5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle\n10. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n11. Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\\u003C 6 months is excluded.\n2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.\n4. Index ulcer and\u002For index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled\n5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n7. A subject with a previous partial amputation on the affected leg is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n8. If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he\u002Fshe is excluded.\n9. If a subject has a serum creatinine ≥ 3.0mg\u002FdL within 6 months of randomization he\u002Fshe is excluded.\n10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1\u002Frandomization visit during which time the subject received SOC.\n11. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n12. A potential subject with end stage renal disease requiring dialysis is excluded.\n13. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n14. A subject treated with hyperbaric oxygen therapy or a Cellular and\u002For Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded",{"count":48,"type":21},[51],"The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following:\n\n* Rate of wound closure\n* Change in ulcer size over 12 weeks\n* Any adverse events or reactions (side effects)\n* Change in pain levels\n* Occurrence of infection",[75],"Venous Leg Ulcers","2025-01-07",{"date":78,"type":30},"2025-01-09",{"date":60,"type":30},{"date":62,"type":21},{"name":36,"class":37},""]