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Active clinical trials for "Gangrene"

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MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

Diabetic FootGangrene; Limb5 more

Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut. For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen. Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.

Recruiting5 enrollment criteria

Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort

Joint OsteoarthritisAtherosclerosis of the Distal Arteries6 more

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of "dysmobility" in patients with chronic illness

Recruiting11 enrollment criteria

SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national...

Necrotizing FasciitisFournier Gangrene1 more

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not. The objectives of the study are : To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

Recruiting4 enrollment criteria

Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)

Peripheral Vascular DiseasesArterial Occlusive Diseases3 more

The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.

Completed11 enrollment criteria

Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections

FasciitisNecrotizing2 more

Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.

Completed31 enrollment criteria

Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear...

Critical Limb IschemiaAtherosclerosis2 more

The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.

Completed14 enrollment criteria

Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous...

Gangrenous Appendicitis

A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.

Completed6 enrollment criteria

Stem Cell Study for Patients With Leg Ulcer/Gangrene

Leg PainUlcer3 more

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Completed29 enrollment criteria

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft...

Necrotizing Soft Tissue InfectionsNecrotizing Fasciitis1 more

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

Completed33 enrollment criteria

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Necrotizing Soft Tissue InfectionNecrotizing Fasciitis2 more

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

Completed8 enrollment criteria

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