[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-wound-care\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-wound-care":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,85,111,133],{"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":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100643240","the-warm-study-is-a-pilot-study-that-aims-to-investigate-the-impact-of-environmental-factors-on-acute-and-chronic-wounds-mental-illness-and-social-factors-among-people-experiencing-housing-emergencies-in-augsburg-100643240",false,"NCT07640672","The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg.","Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg","WARM","Inclusion Criteria:\n\n* Age over 18\n* Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians\n* Inclusion of patients who present for wound treatment at the Johanniter-Hilfsmobil, the wound consultation hour of the Clinic for Vascular Surgery at Augsburg University Hospital and\u002For the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital\n* Written consent to participate in the study has been obtained from the test subject.\n\nExclusion Criteria:\n\n* Minderjährigkeit\n* Fehlende schriftliche Einwilligung zur Studienteilnahme\n* Instabiler somatischer Zustand der Betroffenen\n* Akute Selbst- und Fremdgefährdung","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study.\n\nThe aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital.\n\nIn addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.\n\nAnother focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.",[27,28,29,30,31,32,33,34],"Homeless Persons","Wound and Injuries","Chronic Wound Care","Homelessness","Environmental Health","Environmental Factors","Psychiatric Disorders","Drug Abuse\u002FDependence",[36,37,38,39,40,41],"wound care","environmental health","wound and injuries","homeless persons","psychiatric disorders","drug abuse\u002Fdependence","NOT_YET_RECRUITING","2026-06-05",{"date":45,"type":46},"2026-06-11","ACTUAL",{"date":48,"type":21},"2026-06-01",{"date":50,"type":21},"2027-12-31",{"name":52,"class":53},"University Hospital Augsburg","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100637979","short-term-safety-and-performance-of-two-wound-dressings-evaluation-100637979","NCT07576322","Short-Term Safety and Performance of Two Wound Dressings Evaluation","A Post-Market Clinical Follow-Up Study to Evaluate Short-Term Safety and Performance of POLTX_Fiber Compared With Suprasorb Liquacel Pro in Chronic Wounds","POLTX_Fiber","Inclusion Criteria:\n\nAge ≥ 18 years Chronic wound of 4 weeks to 2 years in duration Moderate to highly exuding wound (clinician-assessed) Wound area 2-50 cm² after debridement Able and willing to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\nKnown hypersensitivity to study or comparator dressing components Clinically infected wound requiring systemic antibiotics at baseline Necrotic wound (\\>25% necrotic tissue) or malignant wound Severe arterial insufficiency (ABI \\\u003C 0.5) Pregnant or breastfeeding Severe comorbid condition likely to interfere with wound healing or safety evaluation (e.g., end-stage renal disease, active cancer on chemotherapy, immunosuppression) Participation in another interventional study within 30 days Use of investigational wound products within 30 days Cognitive or psychiatric condition limiting consent or compliance Unable to attend follow-up visits or likely to relocate during the study period Any condition that, in the investigator's judgment, may compromise safety or study integrity",{"count":64,"type":21},60,[24],"Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection.\n\nStandard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX\\_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking.\n\nA post-market clinical follow-up study will compare POLTX\\_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.",[29,68,69],"Local Infection","Safety",[71,72,73,74],"chronic wound","local infection prevention","wound exudate","safety","2026-05-04",{"date":77,"type":46},"2026-05-08",{"date":79,"type":21},"2026-06-15",{"date":81,"type":21},"2027-09-30",{"name":83,"class":53},"Sebastian Probst",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100612807","mailuo-shutong-pills-for-diabetic-wound-healing-a-multicenter-randomized-trial-100612807","NCT07258381","Mailuo Shutong Pills for Diabetic Wound Healing: A Multicenter Randomized Trial","A Multicenter, Randomized Controlled Trial on the Efficacy of Mailuo Shutong Pills in Treating Diabetic Wounds With Damp-Heat Toxin Accumulation Syndrome","Inclusion Criteria:\n\n* a confirmed diagnosis of type 1 or type 2 diabetes mellitus;\n* the type of wound is an ulcer, with an ulcer area ranging from 1 to 40cm ²;\n* the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;\n* The traditional Chinese medicine diagnosis is Damp-Heat Toxin Accumulation Syndrome;\n* voluntary participation in the study and signing of an informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis of a Cold Pattern according to Traditional Chinese Medicine (TCM) differentiation, manifested as: pale, enlarged, and tender tongue with a white, moist or glossy coating; pallor; pale lips; aversion to cold with a preference for warmth; and loose stools.\n* Pregnancy or lactation.\n* Presence of severe, uncorrected systemic diseases, such as acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure.\n\nActive bleeding within the wound that prevents the implementation of standard wound care.\n\n* Severe laboratory abnormalities: serum albumin \\\u003C 20 g\u002FL; hemoglobin \\\u003C 60 g\u002FL; or platelet count \\\u003C 50 × 10⁹\u002FL.\n* Diagnosis of advanced malignant tumor.\n* Active phase of an autoimmune disease.\n* History of hypersensitivity to Mailuo Shutong Pills or Mailuo Shutong Granules.\n* Inability to cooperate with the study procedures or presence of psychiatric disorders.\n* Any other condition considered by the investigator as a clear, unmodifiable factor adversely affecting wound healing, making the candidate unsuitable for the study or unable to comply with the study requirements.","80 Years",{"count":94,"type":21},56,[24],"Mailuo Shutong Pills are a Chinese patent medicine approved for market release by the China Food and Drug Administration (CFDA) in 2009. It is formulated by integrating five classical herbal formulas, including Ermiao San, Simiao Yongan Tang, and Zhijing San. Its composition is as follows: Honeysuckle Flower (Jinyinhua) serves as the principal component (Jun herb) for clearing heat and detoxifying; Astragalus Root (Huangqi) for tonifying qi, expelling toxin, and promoting diuresis; Phellodendron Bark (Huangbai), Atractylodes Rhizome (Cangzhu), and Coix Seed (Yiyiren) act as deputy components (Chen herbs) to clear heat and resolve dampness; Chinese Angelica (Danggui), Peony Root (Baishao), and Licorice Root (Gancao) alleviate spasm and pain; Figwort Root (Xuanshen) cools the blood, clears heat, drains fire, detoxifies, and softens hard masses. Leeches (Shuizhi), Centipede (Wugong), and Scorpion (Quanxie) serve as assistant components (Zuo herbs) to invigorate blood, resolve stasis, attack toxicity, dissipate nodules, and unblock collaterals to relieve pain. Licorice Root (Gancao) also harmonizes the various components in the formula as the envoy component (Shi herb). The complete formula possesses the effects of clearing heat and detoxifying, dissolving stasis and unblocking collaterals, and dispelling dampness and reducing swelling. It is indicated for various conditions differentiated in Traditional Chinese Medicine (TCM) as presenting with a pattern of dampness-heat and stasis obstruction, such as superficial thrombophlebitis and deep vein thrombosis in the non-acute stage.\n\nSome studies suggest that Mailuo Shutong Pills may have a positive effect in the field of wound healing, for example, by significantly reducing the release of inflammatory mediators such as IL-1β, IL-6, CRP, and TNF-α caused by inflammatory diseases \\[11-13\\], and accelerating the healing of diabetic foot wounds \\[14\\]. Clinical guidelines, including the \"Clinical Application Guide for Chinese Patent Medicines - Diabetes Volume\" from the Diabetes Branch of the China Association of Chinese Medicine and the \"Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Diabetic Foot\" from the Chinese Medical Doctor Association, recommend Mailuo Shutong Pills for the treatment of diabetic foot ulcers \\[15\\]. However, the current related evidence-based medical evidence is insufficient. We have also observed that the adjunctive use of Mailuo Shutong Pills does not guarantee a shortened healing time for all patients with diabetic wounds. From a TCM perspective, the presence of a dampness-heat and stasis obstruction pattern is a key factor determining the efficacy of adjunctive Mailuo Shutong therapy. For Western medicine practitioners, tongue diagnosis presents a practicable factor for assessing pattern manifestation. Therefore, based on differences in patient patterns and using tongue appearance as an inclusion\u002Fexclusion criterion, to screen for the indications of Mailuo Shutong Pills combined with existing standard treatment for diabetic wounds constitutes an effective technical approach to address the aforementioned issues.\n\nConsequently, this study aims to explore the indications for Mailuo Shutong Pills in diabetic wounds and obtain evidence-based medical evidence for its clinical efficacy within an integrated Chinese-Western medicine approach. Furthermore, to enhance the study's external validity and participant recruitment efficiency, thereby accelerating the research progress, this study is designed as an exploratory trial conducted across multiple centers.",[98,29],"Diabetic Wound",[100,101],"diabetic wound","chronic wound care","2025-11-30",{"date":104,"type":46},"2025-12-02",{"date":106,"type":21},"2025-12-01",{"date":108,"type":21},"2027-12-01",{"name":110,"class":53},"Peking University Third Hospital",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":54},"100600387","efficacy-of-tetrachlorodecaoxide-tcdo-drops-in-chronic-wound-healing-100600387","NCT07096830","Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing","Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial","TCDO-Wound","Inclusion Criteria:\n\n* Adults \\> 18 years diagnosed with chronic wounds (duration \\> 6 weeks)\n* Wound size between 5 and 10 cm²\n* Adequate perfusion:\n* Ankle-Brachial Pressure Index (ABPI) \\> 0.8 for venous leg ulcers\n* Palpable pulses for diabetic foot ulcers\n\nExclusion Criteria:\n\n* Patients receiving immunosuppressive therapy or corticosteroids\n* Presence of malignancy\n* Patients who do not provide informed consent",{"count":120,"type":21},66,[24],"This is a single-center, randomized controlled trial evaluating the effectiveness of topical tetrachlorodecaoxide (TCDO) solution in enhancing chronic wound healing. The study will compare standard wound care with and without the addition of topical TCDO drops. Eligible adult participants with chronic wounds of more than six weeks' duration will be randomly assigned to either the intervention or control group. The trial aims to assess the rate of wound healing, time to 50% wound closure, pain reduction measured by the Visual Analog Scale (VAS), and cost-effectiveness.",[29],"2025-07-31",{"date":126,"type":46},"2025-08-05",{"date":128,"type":21},"2025-08-30",{"date":130,"type":21},"2026-08-30",{"name":132,"class":53},"Fazeelat Bibi",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"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":141,"type":21},30,[143],"PHASE2","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.",[146,147,148,149,150,29],"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)",[152,153,154,155,29],"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":159,"type":46},"2025-06-12",{"date":161,"type":46},"2025-04-15",{"date":163,"type":21},"2026-08-15",{"name":165,"class":166},"Estar Medical dba Medical Technologies, LTD","INDUSTRY",2]