Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
Diabetic FootDiabetic foot complications care represent a significant burden to the Canadian healthcare system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than $150 million. A small sized randomized controlled trial (n=17) investigating the use of topical oxygen therapy (n=9) against placebo (n=8) for diabetic ulcers was done recently and showed a 87% average reduction of ulcer size in treatment group versus 46% average reduction in the control group (p<0.05). Despite the standards of care used today in diabetic foot ulcer treatment, wounds may be non-healing when they do not heal within the appropriate time frame expected by an experienced clinician. Current diabetic foot ulcer standards of care include: full medical assessment in all cases, surgical intervention where indicated and local treatment of the ulcer. Given the scarcity of controlled trials specifically designed to review the effects of topical oxygen in ulcer care, this study will contribute to the understanding of the management of these ulcers by assessing the reductions in ulcer size achieved using Natrox™ topical oxygen therapy.
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment...
WoundsDiabetic Foot Ulcers1 moreThe purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Diabetic Foot UlcerOffloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.
Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers
Diabetic Foot UlcerThe primary objective is to evaluate the efficacy and safety of the use of a formulation of snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot. The secondary objetives: To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot with respect to the standard of care, by means the application of patchs that containing the formulation in a treatment period of until 60 days. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) in diabetic individuals in a treatment period of until 60 days.
Moleculight i:X™ in Wound Healing
Ulcer FootDiabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15. A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection. This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall. Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
Effect of Local Application of Boron on Diabetic Foot Ulcers
Diabetic Foot UlcerBoron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
Diabetic Foot UlcersThe purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.
Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics
DiabetesFoot Ulcers1 moreThe 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
Bioburden Reduction of Diabetic Foot Ulcer
Diabetic Foot UlcerStudy to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer
Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers...
Stem Cell TransplantThis study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer