View clinical trials related to Foot Ulcer.
Filter by:Foot ulceration is a common and costly complication of diabetes. GSK1278863 is a topical drug, which is being developed to treat wounds associated with DFU. The aim of this study is to explore the symptoms and impacts of DFU from the subject perspective and to elicit in-depth information about DFU signs and symptoms, impacts on functioning and health-related quality of life (HRQoL). Adult DFU subjects with current or recent (within last six months) neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional interview study. Approximately 20 DFU subjects will be recruited from up to three clinical sites. Potential subjects will be pre-screened and then contacted to gauge interest in the study. Interested subjects will be screened and eligible subjects will consent to release contact information to research staff. Research staff will contact the subject to schedule interviews. This study will include concept elicitation interviews over the telephone or in-person by trained and experienced interviewers. In-person interviews will be conducted in a private room at the clinical site. All interviews will be conducted in English and will be guided by semi-structured interview guides. All subjects will provide written consent prior to the start of the interview.
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and represents a big economic burden for the society. No specific therapy is available for diabetic foot ulcers.The aim of this study is to define a new approach for treatment of chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1 inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The primary objective of the study will be the reduction with >50% of the wound area after 12 weeks of treatment.
(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This dressing has been categorised as Class III medical device. This clinical study will be conducted in patients with diabetic foot ulcers.
Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure, has become a popular therapy for the treatment of many acute and chronic wounds. In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers routinely used in negative pressure wound therapy, on the healing of the diabetic lower-extremity ulcers and the pressure ulcer. Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups randomly. The letter of consent was signed by the patient or patient's family. After debridement of the infective wound, the wound of experimental group was packed with a moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each time of changing dressing in the following 3 weeks. The percentage of wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were analyzed using linear mixed mode with SPSS statistical software. This clinical study was approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.
Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene. A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc). The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors. The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain. The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, the temporal pattern of pain will be assessed by asking the participants to fill out a form stating subjective level of pain (NRS) every hour during a typical day, and to mark times that they rest and sleep. Relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination.
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing properties through releasing pro-healing factors and regulating angiogenesis. When used combination there is evidence of additional wound healing benefits. The aim is to investigate the feasibility of conducting a randomised controlled trial with fat grafting and fat/PRP co-grafting as interventions for diabetic ulcers. We aim to develop pilot data which can power a multi-centre study. The aim of the trial would be to determine the feasibility of the trial by assessing recruitment, randomisation and retention of participants. We would also evaluate the rate of wound healing in diabetic ulcers when treated with conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will be to understand the mechanism of the healing process, the health related quality of life and patient satisfaction and the cost implications. The study is a single-blinded randomised controlled trial of approximately 30 patients with three parallel treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and will undergo subsequent histological analysis to evaluate the mechanism of healing. The study is expected to last two years from recruitment of the first patient and will be conducted at Royal Free Hospital and UCL Division of Surgery and Interventional Science. The combination of fat+PRP may provide diabetic patients the option of a single treatment with improved healing, shorter followup and a reduced cost burden. Validation of the mechanism of healing through histological analysis will confirm clinical findings and help guide future research.
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing. The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.