[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,72,101,127,153,176],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100452483","diabetic-foot-ulcer-dfu-biofilm-infection-and-recurrence-100452483",false,"NCT05172089","Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence","DFUBiofilm","Inclusion Criteria:\n\n* Male or Female, Age ≥ 18\n* Willing to comply with protocol instructions, including all study visits and study activities.\n* Patient with an open Diabetic Foot Ulcer\n* Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):\n* TcOM \\>30 mmHg\n* Ankle-brachial index at least ≥0.7\n* Toe pressure \\> 30 mmHg\n* TBI \\> 0.6 mmHg\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.\n* Wounds closed or to be surgically closed by flap or graft coverage\n* Subjects with marked immunodeficiency (HIV\u002FAIDS, or on immunosuppressive medications.\n* TcOM \\\u003C 30mmHg\n* Diabetics with a hemoglobin A1c \\> 15 within 3 months prior to enrollment\n* Subject with autoimmune connective tissue disease\n* Ulcer size and location that does not allow the TEWL measurement per SOP\n* Pregnant women\n* Prisoners\n* Unable to comply with study procedures and\u002For complete study visits","ALL","18 Years",{"count":19,"type":20},405,"ESTIMATED","OBSERVATIONAL","This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.",[24,25,26,27,28],"Chronic Wounds","Biofilm Infection","Trans-epidermal Water Loss (TEWL)","Diabetic Foot","Diabetic Foot Infection",[30,31,32,33],"foot ulcer","diabetic foot","wound infection","diabetic foot ulcer","RECRUITING","2026-03-14",{"date":37,"type":38},"2026-03-18","ACTUAL",{"date":40,"type":38},"2024-04-02",{"date":42,"type":20},"2029-06-27",{"name":44,"class":45},"University of Pittsburgh","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100467613","phase-3-safety-and-efficacy-study-of-contezolid-acefosamil-and-contezolid-compared-to-linezolid-administered-intravenously-and-orally-to-adults-with-moderate-or-severe-diabetic-foot-infections-dfi-100467613","NCT05369052","Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)","A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)","Inclusion Criteria:\n\n* Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria\n* Have a foot infection that started at or below the malleolus and does not extend above the knee\n* Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection)\n* Foot infection had acute onset or worsening of signs and symptoms within the past 14 days\n\nExclusion Criteria:\n\n* Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics\n* DFI with presumptive evidence or suspicion of osteomyelitis\n* Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, septic arthritis, or severely impaired arterial supply to any portion of the affected foot which may need revascularization before the end of the study\n* Evidence of significant hepatic, renal, hematologic, or immunologic disease\n* Females who are pregnant or breastfeeding\n* Prior receipt of any formulation of contezolid acefosamil or contezolid\n* Inability to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be noncompliant with any study requirements, or the Investigator determines that the subject should not participate in the study",{"count":55,"type":20},865,"INTERVENTIONAL",[58],"PHASE3","This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)\u002Fcontezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.",[28],"2025-09-09",{"date":63,"type":38},"2025-09-10",{"date":65,"type":38},"2022-05-03",{"date":67,"type":20},"2026-06-30",{"name":69,"class":70},"MicuRx","INDUSTRY",14,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":56,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":100},"100567404","randomized-double-blind-trial-on-safety-and-efficacy-of-nanordica-advanced-antibacterial-wound-dressing-for-diabetic-foot-ulcer-100567404","NCT06667752","Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer","A Randomized, Double Blind, Active Controlled, Parallel Group Clinical Trial to Assess the Safety and Efficacy of Nanordica Antibacterial Wound Dressing in Patients With DFUs","NM2023","Inclusion Criteria:\n\n* Voluntary, written informed consent obtained prior to any study related activities.\n* Males and females aged ≥18 years.\n* DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm.\n* IWGDF\u002FIDSA Wound infection grades 1 (absent) or 2.\n* Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.\n* Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg.\n\nExclusion Criteria:\n\n* Ssystemic or topical antibiotic therapy within 7 days before the enrolment.\n* Any wound with known associated osteomyelitis or positive probe-to-bone test.\n* Previous randomization in this clinical trial.\n* Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study.\n* Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks.\n* Patients suffering cardiac disorders grade NYHA IV.\n* Patients suffering hepatic disorders grade Child-Pugh C.\n* Stage 4 cancer.\n* Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.",{"count":81,"type":20},170,[83],"NA","This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.\n\nAt least 170 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.",[86,28],"Diabetic Foot Ulcer",[88,89,90,91],"DFU","Diabetic foot ulcer","Diabetic foot infection","Chronic ulcer","2025-08-26",{"date":94,"type":38},"2025-08-27",{"date":96,"type":38},"2024-10-17",{"date":67,"type":20},{"name":99,"class":70},"Nanordica Medical OU",11,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":56,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":5},"100486431","photofinish-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-the-system-vulnofast-plusvulnolight-in-addition-to-the-usual-care-uc-vs-uc-alone-for-the-treatment-of-infected-diabetic-foot-ulcers-100486431","NCT05613985","PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus\u002FVULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers","A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus \u002F VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH)","PHOTOFINISH","Main Inclusion Criteria:\n\n* Able and willing to give voluntary written informed consent. The ICF, must be signed before any study-related procedures and\u002For assessments are performed.\n* Outpatients or inpatients (male and female) of any ethnic origin, aged 18 years or over, diagnosed with type 1 or type 2 diabetes mellitus.\n* Glycaemic control confirmed by a glycated haemoglobin (HbA1c) levels ≤10% (86 mmol\u002Fmol), evaluated in the 3 months before enrolment or at Visit 1.\n* Fasting plasma glucose (FPG) less than 300 mg\u002Fdl.\n* A chronic diabetic foot ulcer (DFU) below the malleolus, with an area ≥ 2 and ≤ 40 cm2 and with a maximum diameter\u002Flength ≤ 10 cm measured by MolecuLight i:X medical device \\[note: chronic wound is defined as a wound that, after the normal clinical practice, does not start healing within 4 weeks or does not heal within 8 weeks\\].\n* A diabetic foot wound with a depth equal or higher to grade 2 according to the category \"Depth\u002Ftissue loss\" of PEDIS, but not involving bone, diagnosed by clinical examination.\n* Presence of infected foot ulcer of grade 2 according to the category \"Infection\" of PEDIS, diagnosed by clinical examination.\n* Able to take oral medications.\n* Patients must be willing and able to comply with the protocol and study procedures.\n\nMain Exclusion Criteria:\n\n* Patients unable to give written informed consent.\n* Females who are pregnant or lactating.\n* Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.\n* Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to Visit 1.\n* Ankle brachial systolic blood pressure index \\\u003C 0.5 (Winsor Index) in the infected limb.\n* Ulcer probe to bone positive.\n* Any surgery planned during the study period (from ICF signature to last planned follow-up visit).\n* Clinical diagnosis of peripheral vascular disease (PVD) requiring percutaneous or surgical revascularization.\n* Transcutaneous oximetry (TcPo2) measurement \\\u003C 30 mmHg.\n* Use of any antibiotics (local or systemic) within 48h before Visit 1.\n* Patient for whom punch biopsy is contraindicated.\n* Patients that cannot take amoxicillin and clavulanic acid (background antibiotic therapy) at the dosage stated in the protocol and according to the current Summary of Product Characteristics (SPC).\n* Patients that cannot be treated with topical antiseptic containing Iodopovidone and\u002For with iodopovidone impregnated gauze according to the contraindication available in the current Summary of Product Characteristics (SPC).",{"count":110,"type":20},78,[83],"The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus \u002F VULNOLIGHT® to the Usual Care, versus the treatment with Usual Care alone, for the healing of chronic diabetic foot ulcer. VULNOFAST® plus is a sterile solution used in combination with a red light source VULNOLIGHT®. Usual Care is defined as procedures to apply to the foot ulcer, carried out in the order in which they are listed in the protocol.",[28],[115,89,88,116,117,118],"Infected diabetic foot ulcer","Infected diabetic wound","Photodynamic therapy","PDT","2025-08-04",{"date":121,"type":38},"2025-08-08",{"date":123,"type":38},"2021-09-14",{"date":67,"type":20},{"name":126,"class":70},"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100596056","study-of-infrared-thermography-in-diabetic-foot-in-guadeloupe-100596056","NCT07040488","Study of Infrared Thermography in Diabetic Foot in Guadeloupe","Study of Infrared Thermography in Diabetic Foot in Guadeloupe (ETPDG)","ETPDG","Inclusion Criteria for Control Group\n\n* Adult patients\n* Patients of Afro-Caribbean origin\n* Volunteer patients free from pathology\n* Person affiliated to or beneficiary of a social security scheme.\n* Person who has agreed to sign a consent to participate in the study\n\nInclusion Criteria for diabetic patients:\n\n* Adult patients\n* Patients of Afro-Caribbean origin\n* Type 1 or type 2 diabetic patients with and without diabetic foot ulceration\n* Person affiliated to or beneficiary of a social security system.\n* Person who has agreed to sign a consent to participate in the study\n\nExclusion Criteria :\n\n* \\- Minors\n* patient with an active fracture or a history of fracture\n* a history of legs surgery\n* History of amputation\n* Bilateral diabetic ulceration\n* neurological disease (Parkinson, stroke, etc.)\n* pregnancy\n* Foot mycosis\n* refusal of consent",true,{"count":137,"type":20},150,"It is hypothesized that thermal imaging differs between diabetic and non-diabetic individuals in Guadeloupe. Infrared thermography is also suggested as a useful tool for studying diabetic foot ulceration. The main objective is to compare the temperatures of four areas of the plantar surface of the foot among non-diabetic individuals, diabetic individuals, and diabetic individuals with foot ulceration.",[28],[141,31,142],"Infrared thermography","infection","2025-06-18",{"date":145,"type":38},"2025-06-27",{"date":147,"type":38},"2024-09-27",{"date":149,"type":20},"2026-03-27",{"name":151,"class":45},"Centre Hospitalier Universitaire de la Guadeloupe",1,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":56,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100517645","phase-2-nu-3-gel-for-infected-diabetic-foot-ulcers-100517645","NCT06020235","Nu-3 Gel for Infected Diabetic Foot Ulcers","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy of Topically Once or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% and 10% Concentrations to Infected Diabetic Foot Ulcers (iDFU)","Inclusion Criteria:\n\n* 1\\. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.\n\n  3\\. Non-hospitalized ambulatory subjects diagnosed with diabetes mellitus, Type I or II per ADA criteria with signs of a localized mild foot infection as defined by the IDSA infection severity criteria (Lipsky,2012)\n\n  a. the presence of purulent drainage or at least two of the following criteria: i. erythema, ii. warmth, iii. pain or tenderness, iv. edema, or v. induration (The diagnosis of mild infection must be confirmed immediately following debridement at Baseline).\n\n  4\\. The target ulcer is classified as a grade 1 ulcer according to the Wagner Scale (Wagner 1979). The ulcer is a superficial, full-thickness ulcer limited to the dermis, not extending to the subcutis. Target ulcer is \\>1 cm2 and \\\u003C12 cm2 post debridement at baseline and must be no higher than the ankle, on or below the malleolus (ankle bone) with ≥50% below the malleolus.\n\n  5\\. Adequate vascular perfusion as evidenced by one of the following:\n  1. Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg\n  2. Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.\n  3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \\>0.75.\n\n     6\\. Subject has a caregiver who will attend the Baseline visit (V2) and\u002For watch the dosing and dressing demonstration video and apply wound treatment along with study dressings for the study duration.\n\n     7\\. Must meet one of the following criteria:\n\n  a. Female subjects of Non-Child-Bearing Potential i. Postmenopausal for at least 1 year ii. Surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening) iii. Bilateral tube ligation \\> 6 months prior to screening iv. A negative serum β-hCG pregnancy test at screening and no breastfeeding after the administration of the study drug.\n\n  b. Male subjects of Non-Childbearing Potential defined as: i. Vasectomized subjects for \\> 6 months prior to Screening ii. Those diagnosed as sterile by a physician. c. Females and Males of Childbearing Potential who practice an acceptable method of contraception defined as the i. Use of any form of hormonal contraceptive ii. Use of a barrier method with spermicide, condoms, intrauterine device, iii. Abstinence from sexual intercourse starting at least 60 days prior to Screening and continuing at least 14 days following the last treatment.\n\n  8\\. Subjects must be willing to undergo all clinical investigation-related procedures, attend all required visits, and cooperate fully with the investigator and site personnel.\n\n  9\\. Subject must be willing to wear offloading RCW, if necessary, throughout the duration of the clinical treatment.\n\n  10\\. Subject must have plain radiograph taken at screening and prior to randomization showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.\n\nExclusion Criteria:\n\n* 1\\. Ulceration with exposed tendon, capsule, or bone 2. IDSA-defined moderate or severe DFU infection. 3. Infected diabetic foot ulcer that is associated with local wound complication such as prosthetic materials or protruding surgical hardware.\n\n  4\\. \\> 1 infected foot ulcer 5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.\n\n  6\\. Subject has received a systemic antibiotic within 48 hours prior to Screening.\n\n  7\\. Concurrent or expected to require systemic antimicrobials during the study period for any infection including diabetic foot ulcer.\n\n  8\\. Any subject that has active viral hepatitis (A, B, C) and\u002For untreated HIV\u002FAIDS.\n\n  9\\. Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation 10. eGFR \\\u003C60 and\u002For subject on hemodialysis within 3 months prior to randomization.\n\n  11\\. Hemoglobin A1c (HbA1c) \\>12% within 3 months prior to randomization. 12. Aspartate Aminotransferase (AST, GOT) and\u002For Alanine Aminotransferase (ALT, GPT) \\>3.0 x the upper limit of normal and\u002For bilirubin \\>1.5 x the upper limit of normal within 3 months prior to randomization.\n\n  13\\. Acute active Charcot foot 14. Any subject that would be unable to safely monitor the infection status at home and return for scheduled visits.\n\n  15\\. History of immunosuppression within 3 months prior to randomization, or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg\u002Fday or less for chronic conditions 16. Any subject with a life expectancy ≤ 6 months 17. Use of investigational drugs within 28 days prior to screening 18. Use of Aspirin® or acetylsalicylic acid containing medication (except low-dose aspirin) \\\u003C 7 days before baseline, 19. Use of oral anticoagulants (e.g., warfarin, Xarelto® or comparable products).\n\n  20\\. History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol including known or suspected active abuse of alcohol, narcotics, or non-prescription drugs.\n\n  21\\. Prior randomization in this clinical trial, or a previous Bisphosphocin study",{"count":161,"type":20},60,[163],"PHASE2","The goal of this clinical trial is to test a topical drug in patients with mild infections of their diabetic foot ulcer. The main questions it aims to answer are:\n\nWhat strength does the drug need to be in order to make the infection better? How frequently does the drug need to be applied in order to make the infection better? Participants will be asked to apply the medicine on their foot ulcer twice a day for 2 weeks and remain off of that foot during that time.\n\nParticipants will receive the medication either once a day or twice a day, in either a 5% or 10% gel, or placebo.\n\nResearchers will compare the 5% and 10% gels to placebo to see if the infection improves.",[28],"NOT_YET_RECRUITING","2025-03-03",{"date":169,"type":38},"2025-03-06",{"date":171,"type":20},"2025-12",{"date":173,"type":20},"2026-08",{"name":175,"class":70},"Lakewood-Amedex Inc",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":56,"phases":187,"briefSummary":189,"conditions":190,"keywords":199,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":207,"locationsCount":152},"100486191","phase-1-efficacy-of-adipose-tissue-derived-stem-cells-for-the-treatment-of-diabetic-foot-ulcers-100486191","NCT05610865","Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers","Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds","Inclusion Criteria:\n\n* Type 1 or Type 2 Diabetes Mellitus\n* Age 20-60 years (Male\u002FFemale)\n* Body mass index 20-30 kg\u002Fm2\n* Suitable for liposuction\n* Condition or Disease: Diabetic Neuropathy\n* Wound Type: Chronic foot ulcer\n* Approx. wound area: 2 cm2 - 8 cm2\n* Wound Condition should be of Wagner's grade I (Limited to soft tissue)\n* Duration of wound persistence: 6-24 Weeks\n* Transcutaneous oxygen pressure \\> 30 mmHg, and an ankle brachial pressure index \\> 0.5.\n* Already following an adequate off-loading method\n* Provided signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled hyperglycemia (HbAlc \\> 9%)\n* Presence of severe clinical sign of infection\n* Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.\n* Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases\n* Patients with critical limb ischemia and osteomylitis\n* Withdrawal of informed consent","20 Years","60 Years",{"count":186,"type":20},28,[188],"PHASE1","The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.",[86,191,27,28,192,193,194,195,196,197,198],"Diabetes Mellitus","Diabetic Foot Ulcer Neuropathic","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Foot Ulcer","Diabetes Complications","Chronic Diabetic Ulcer of Left Foot","Chronic Diabetic Foot Ulcer of Right Foot",[200],"Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)","2024-12-30",{"date":203,"type":38},"2024-12-31",{"date":205,"type":38},"2020-11-20",{"date":171,"type":20},{"name":208,"class":45},"University of the Punjab"]