24 Clinical Trials for Various Conditions
This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds
This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an emerging surgical and wound care treatment. This investigation aims to demonstrate that patients with chronic, non-healing wounds treated with autologous PRP and standard medical care have a reduction in wound volume and improved healing rate that results in patient-centered clinically significant health outcomes as compared to patients treated with standard medical care only.
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.
To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.
The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the effectiveness and safety of various NPWT devices and methods among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these Randomized Controlled Trials (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among typical patients. Patient registries are also ideal for assessing long term safety issues in these devices.
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.
Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers
Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.
The goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is: - Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period? Patients will be treated with: * OCM™ Wound Matrix * Omeza combination therapy * Standard of Care
The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown little success in healing diabetic foot wounds. The investigators' laboratory and animal work has suggested that a safe medication, currently used as an eye drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to test this drop (timolol) directly on the surface of the foot ulcer to see if can improve healing faster than the current standard of care. To do this, the investigators propose a "randomized controlled trial" with two groups of patients with diabetic foot ulcers: one will receive standard of care with timolol while the other will receive standard of care with a gel (hydrogel, as placebo medicine).
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.
Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.
The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of care. Patient outcomes will be compared at the end of the study.
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)
Collect data on various wound/injuries treatments and their related wound healing process, in real life settings. Over a 12-week period per wound treated. Analyze the safety and efficacy of wound treatments, including advanced biological/synthetic grafts with designations of 361 HCT/Ps or 510(k) FDA clearance and standard of care wound treatments.
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.
The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. The main outcome studied is healing of ulcers after 12-weeks, along with other outcomes such as occurrence of infection, complications, and antimicrobial use. Medical records from the past were reviewed, where patients receiving the MolecuLight procedure were compared to those who did not.
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care. Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human wound edge tissue is associated with poor healing outcome in a setting of standard clinical care. This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled diabetic, and, who have chronic venous leg ulcers that have been open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be recruited from the Indiana University Health Comprehensive Wound Center (CWC). On days 0, 14 and 28, patients will have the following performed: measurements and photographs taken of their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen in the wound tissue, if receiving a tissue biopsy; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will not be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical records will be reviewed throughout the study for 98 days (14 weeks) after enrollment to determine the final status of the wound as healed or not-healed. ABI will be completed per study personnel at initial visit for all consented subjects to ensure subject eligibility (as listed TCOM\<30 mmHg in exclusion criteria). If ABI's are unable to be obtained, TCOM will be performed. There will be a total of 5 visits for this study (6 total visits for patients with open wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21,28.