View clinical trials related to Diabetic Foot Ulcer.
Filter by:This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death. Conventional treatment of DFUs are time consuming, burdensome, costly, and often do not treat the root cause of the problem. Even with proper care, ulcers can take a significantly longer time to heal in diabetic patients due to the altered physiology which does not allow for the proper nutrients and healing factors to mobilize to the site of injury, leaving these ulcers with a poor chance of healing and at high risk for infection and possible amputation. Supplemental immunonutrition therapy may offer a viable, low cost, rapidly scalable, and widely available approach to enhance the body's ability to heal itself. This prospective, randomized pilot study will evaluate the effect of a 6-week daily oral course of a specific combination of immunonutrients, L-Arginine, Omega-3 fatty acids, and Vitamin C, on wound healing in diabetic patients with chronic lower extremity ulcers compared to traditional standard of care. The deliverables of this clinical project will serve to advance a cost-effective added strategy to address a significant unmet clinical need in treatment for the diabetic patient population. Study outcomes will lay the foundation for a multi-site clinical trial to establish the efficacy and cost-effectiveness of this strategy across the health care system.
This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The purpose of this study is to demonstrate that the use of Celliant Socks increases tissue oxygenation (via oxygen saturation, StO2) and incidence of wound closure in subjects with diabetic foot ulcers. This study will use hyperspectral imaging and wound assessment to measure these outcomes. The study will enroll 254 evaluable subjects total, 127 per arm to meet the Primary Endpoint. Enrollment may continue up to twenty-five hundred (2500) evaluable subjects total to meet the Key Secondary Endpoint of complete wound closure.
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers. This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing. Participants will be in the study up to one year.
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.
This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.