Active clinical trials for "Foot Ulcer"

This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey

Purpose and significance:With the increasing incidence of Diabetes mellitus (DM), the incidence rate of Diabetic Foot (DF) is raised. DF is a foot infection, ulceration and / or deep tissue destruction caused by nerve abnormalities and varying degrees of vascular lesions in DM patients. The high incidence, disability and mortality rate of DF make it urgent to explore new ways to improve the cure rate, reduce the burden and elevate the quality of life. Previous studies have confirmed that traditional Miao ethic medicine Tangningtongluo(TNTL) can improve the remission rate of diabetes mellitus and diabetic foot disease, but the clinical research evidence is not sufficient. This study aims to provide effective clinical evidence for the treatment of diabetic foot patients with TNTL by observing growth rate of wound, prognosis and outcome. Methods: From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed. Type of study: randomized controlled, prospective,intervention study.

Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis. The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.

The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the ReCell® technology with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.

The purpose of this study is to evaluate the efficacy and safety of monochromatic phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo phototherapy as a complementary to standard diabetic foot ulcer therapy. The study initiated with a four week long Run In Period to eliminate spontaneous healing ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. The area of the ulcer will be measured once weekly for 20 weeks or until the ulcer is completely healed.

The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against usual care. Consenting patients with diabetic foot ulcers (DFUS) and meet the inclusion criteria will be randomly allocated in to either an experimental group or a control group. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is provided by attaching small electrodes around the ulcers to provide electric current stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be assessed and measured and a photograph solely of the wound will be taken for documentation of wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be measured once a week. The movement in participant's ankle will be measured (flexion, extension, inversion) at the start and at the end of the study to see if treatment has improved its movement. As part of this study participants' will also be requested to fill out a SF-36 questionnaire at the start and at the end of the 8 week trial. This questionnaire evaluates a person's health related quality of life in which the research wants to see if it is affected by a diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS® Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The cost of treatment for each arm will be calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.). Therefore, as part of this study, participants will be asked about mode of transport and transport time to and from the clinic and if their diabetic foot ulcer has affected their ability to work. Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring. Data from both groups will be examined and compared to see if CUSECS is effective in healing DFUs. The primary outcome of interest is wound healing and is determined by the number of wounds healed and the time to complete wound healing within eight weeks. All data will be stored confidentially. The study hypothesis is that there is be increased healing rates in subjects treated with CUSECS in combination with standard care compared to those treated with standard care alone. This study aims to provide evidence for continuing improvement in treatment for those suffering with diabetic foot ulcers.

In this prospective pilot study, patients with DFU visiting the Indiana University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound closure(Phase A), and will then begin Phase B where TEWL measurements and wound recurrence will be followed up for up to 12 weeks.