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NCT ID: NCT01686139 Not yet recruiting - Clinical trials for Type II Diabetes Mellitus With Ulcer

Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

Start date: March 2016
Phase: Phase 1
Study type: Interventional

Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world. DM contributes to severe morbidity and mortality due to damage in the target organs (neuropathy, vasculopathy, nephropathy, retinopathy). It affects the quality of life of the patients because of increased rate of blindness, IHD, stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD). Diabetic foot complications are the most common cause of lower extremity amputations in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic patients. Between 15% - 25% of the foot ulcers will lead to lower limb amputations. It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and critical limb ischemia. Stem cells can be obtained from either the patient (autologous) or non-related healthy donors (allogeneic). The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg wounds of diabetic patients.

NCT ID: NCT01491438 Not yet recruiting - Venous Ulcers Clinical Trials

Plasma Rich Growth Factors in Venous Ulcers

Start date: November 2013
Phase: N/A
Study type: Interventional

OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment. SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment. Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit. STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.

NCT ID: NCT01418456 Not yet recruiting - Diabetes Clinical Trials

Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics

KADFUT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form. - All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group. - The antibiotic group will receive standard treatment along with antibiotics. - The control group will have standard treatment alone. - Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks. - Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes

NCT ID: NCT00776854 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Bioburden Reduction of Diabetic Foot Ulcer

Start date: November 2008
Phase: Phase 1
Study type: Interventional

Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer