View clinical trials related to Diabetic Foot.
Filter by:Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition is more frequent in elder patients. It is estimated that about 5% of all patients with diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while 10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb amputation could also be involved in a new amputation in the next year; higher or in the other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading device, wound care and surgery in selected cases. However, treatment of DFU remains challenging because of unsatisfactory results from surgical and non-surgical treatments. Many adjunctive therapies are designed to improve the care of DFU including negative pressure wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB) Hyperbaric oxygen and acellular matrix product among others.
Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds. How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible. The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in. The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. 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, resulting in staggering costs for both the patient and the healthcare system. Prevention by identifying people at higher risk is key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or 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 possibility of gangrene. A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The offloading boot design holds the foot and lower leg in a position that reduces shear and friction forces and provides a reduction in plantar pressure. The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This data will be downloaded at each clinic visit. The boot cannot pump blood around the participant's foot unless fitted correctly and the battery is charged up overnight. The purpose of this study is to conduct an interventional study study with N=15 diabetic subjects with active foot ulcers to assess whether PulseFlow foot compression device can help improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of gait. The key goals of the proposed project are to test whether a specially designed compression device can improve lower extremity perfusion, whilst also simultaneously improving the balance and walking performance. Investigators envision the use of this specially designed offloading device with compression capability will help reduce the incidence of diabetic foot ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device might enhance daily physical activity as well as walking performance. Investigators will conduct a prospective clinical study to validate these hypotheses. Potential changes in walking and spontaneous daily physical activities will be assessed using validated technologies that include walking analyzer system, balance assessment using body worn sensors, and computerized pressure insoles.
This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.
In this study, it was aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation of the diabetic foot infection in the forward direction without using standard scoring procedures.
This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.
This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care of an ACO. After meeting study criteria, participants will be randomly assigned to apply Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6 weeks. Participants will be followed for one year from the date of randomization to assess ulcer status and ulcer complications.