View clinical trials related to Foot Ulcer.
Filter by:This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC. Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot ulcers. Randomization and sample size: Subjects will be allocated on a 1:1 ratio, yielding a minimum per protocol population (PP Population) of 15 patients in the Active group and 15 in the control group. Study timeline: Total amount of time from the Screening Visit to the Final Visit is approximately 16 weeks. For patients who meet inclusion criteria, they are randomized into Active or Control treatment groups. In addition they are stratified into groups based on wound etiology: neuropathic (defined as insensate at 2 or more of 5 sites verified by insensitivity to the 5.07 Semmes-Weinstein 10 g monofilament), ischemic (defined as ABI of 0.7 neuro-ischemic (meeting both of above criteria) Subjects will present at DMU Foot and Ankle Clinic on weeks 0, 3, 6, 9, and 12 for the following measurements: 40mL venous blood draw (VEGF, SDF1a) 2mm punch biopsy (CD34+) Local wound perfusion (Laser Speckle[FK2] ) Ulcer size measured by digital planimetry (TissueAnalytics)
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.