View clinical trials related to Diabetic Foot.
Filter by:The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. We will be evaluating safety, device design and certain human engineering factors associated with point of care use of the TRS. We anticipate the data we collect in this study will form the basis of later medical device studies.
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects.
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers. ◊ Trademark of Smith & Nephew
Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and ischemic etiology. Ulceration of lower limb is one of the most common complications related with diabetes and one of the major causes for hospitalization of diabetic patients. The most significant contributors to diabetic lower limb ulceration are neuropathy, deformity, uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease, male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous burden on health care resources worldwide, and at least 33% of all expenses are spent to treat diabetic ulcers manifested as a complication of diabetes. Although at least 170 topical wound care products are available, evidence of the superiority of one over another is tenuous, well-designed randomized, controlled trials are rare, and the number of case-control or observational studies is limited. In recent years, salve prepared from Norway spruce (Picea abies) resin has successfully been used in medical context to treat both acute and chronic wounds and ulcers of various origins. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of neuropathic diabetic foot ulcer in patients, who are suffering from infected fore- or mid-foot ulceration (PEDIS-classification ≥ Grade II; 19) originated from Type I or II diabetes, and in patients whose diabetic ulcerations are candidates for topical treatment with resin (Study treatment) or octenidine (Control treatment). In addition, factors contributing with delayed healing of ulceration, antimicrobial properties, safety and cost-effectiveness of the resin salve treatment and control treatment will be analyzed.
In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use as a wound covering for dermal ulcers and defects. It is designated as a Human Cell & Tissue Product (HCT/P) by the U.S. FDA.
An open multicenter trial to document the efficacy and safety of two therapeutic Extremely Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot Ulcers.
Diabetes is a multiorgan disease and considered a major health problem in different societies. One of the complications the pain particularly in the extremities resulting from a process known as diabetic foot ulcer. The diabetic patients are subjected to many complications because of foot ulcers, many of them like as chronic wound disease or pressure ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to nursing care and take too long until pain relief. Among many tested materials and works for wound healing such as debridement, tissue oxygenation, and skin transplantation, platelet-derived compounds are allocated the pivotal position between investigators to tissue regeneration and shortening the wound healing process. Many of platelet components are procured from platelet rich plasma (PRP) from whole blood donation. Furthermore, it requires to an additional purification step to diminish the volume and facilitate handling in some studies. It means that platelet concentrates (PCs) may be obtained leading to more concentrated platelets in lower volume. Two types of granules in platelet is responsible for storage of many useful and different growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the ability to growth and differentiation of numerous cells. Also, the antibacterial effect of these growth factors has been reported. To better efficacy and comfortable utilization of platelet, it is feasible to form the platelet gel and then apply on wound sites. This study is a double blind randomized controlled trial to evaluate the positive effects of umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.
This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.