Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Type2diabetesFoot UlcerThe goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Diabetic Foot UlcerPhase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
PLASOMA Ultimate Safety & Efficacy Study
Diabetic Foot UlcerVenous Leg Ulcer5 moreThe purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: FU1: 2 weeks after end treatment period FU2: 12 weeks after end treatment period FU3: 12 months after start treatment.
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered...
Diabetic Foot InfectionThis is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
Optimal Antibiotics for Operated Diabetic Foot Infections
Diabetic Foot InfectionSurgical Wound2 moreDiabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences. This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other. The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies. Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables. Trial 1 (Randomized trial on residual infection after amputation): Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection. Trial 2 (Randomized trial on infection without amputation): Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.
Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers
Diabetic Foot UlcerThe global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment.
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Diabetic Foot UlcerThe global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment.
Total Contact Soft Cast in Diabetic Foot Ulcers
Diabetic Foot UlcerDiabetes Mellitus8 moreTo determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)
Diabetic Foot UlcerThe goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo as an adjunct to SOC. The primary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care (SOC), in the treatment of chronic, non-healing DFUs. The secondary objective is to demonstrate efficacy, safety and tolerability of NOX1416 as adjunct to SOC. Each site will assign a physician (or designee) to serve as the "blinded-evaluator" to be responsible for assessing the study endpoints such as wound measurements and complete wound closure. The blinded-evaluator will not be involved in the clinical care of the subject.
Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
OsteomyelitisDiabetic Foot OsteomyelitisThis is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.