A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers...
Diabetic Foot UlcersThe purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower...
Critical Limb Ischemia (CLI)Diabetic FootThe aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the lower limbs (CLI) without possibility of revascularization or other therapeutic alternatives. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and secrete also several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb...
Peripheral Vascular DiseasesDiabetic FootThe aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue...
Diabetic FootVaricose Ulcer1 moreThe purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers. It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET™ device than with conventional surgical procedures.
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot...
Diabetic Foot UlcerThe purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An...
Diabetic Foot UlcerThe purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a physician or podiatrist), compared with placebo sponge combined with standard of care, in preventing infection of diabetic lower extremity skin ulcers.
A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for...
Foot UlcerDiabeticThis is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.
Removable Walker for Neuropathic Ulcers
Diabetic FootObjective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With...
Diabetic FootDiabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.
VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Diabetic Foot UlcerThe 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.