Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.
This will be a single center, patient-blinded, randomized controlled trial. In the event that a patient does not meet inclusion criteria after signing the consent for and undergoing venogram/IVUS (screen fail), additional patients will be enrolled until 60 patients have been successfully randomized. Up to 80 patients will be consented in order to account for potential screen fails. Randomized patients will be followed monthly until their ulcer heals, every 3 months after healing for one year postoperatively.
Every patient subject will undergo venogram & IVUS. The investigator experience with over 600 patients who underwent venous stenting at Mount Sinai - all of whom had preoperative MR venogram or CT venogram - revealed that pre-operative imaging missed the diagnosis of PVOO in approximately 10% of patients (this is unpublished data). Due to the small sample size of this pilot study, the very low risks associated with venogram and IVUS, and the 100% accuracy of venogram and IVUS in diagnosing PVOO, every study subject will undergo these two imaging studies. Once the diagnosis of PVOO is confirmed, the study subject will be immediately randomized in the OR. Study subjects randomized to convention therapy plus venous stents will undergo venous stent placement at the same sitting. For study subjects randomized to conventional therapy alone, the procedure will be terminated after venogram and IVUS.
Conventional Therapy, Venous Stent(s)
Icahn School of Medicine at Mount Sinai
Not yet recruiting
Icahn School of Medicine at Mount Sinai
Published on BioPortfolio: 2018-01-26T13:20:11-0500
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment o...
This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing ...
This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or t...
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom o...
To show if a combination therapy of rivaroxaban plus Aspirin® is as efficient as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-throm...
Benign central venous thoracic occlusion is a frequent issue in haemodialysis patients. Symptomatic stenosis affects quality of life and can cause dysfunction of arteriovenous access or make it imposs...
Inferior vena cava atresia (IVCA) is a rare vascular condition that may be treated by venous stenting. The authors report on the microsurgical removal of an intraspinally misplaced stent causing nerve...
Diabetes mellitus (DM) plays an important role in restenosis and late in-stent thrombosis (ST). The current study using optical coherence tomography (OCT) aims to compare target lesion neointima in p...
To study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement.
Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.
Impaired venous blood flow or venous return (venous stasis), usually caused by inadequate venous valves. Venous insufficiency often occurs in the legs, and is associated with EDEMA and sometimes with VENOUS STASIS ULCERS at the ankle.
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).
Techniques and strategies which include the use of coding sequences and other conventional or radical means to transform or modify cells for the purpose of treating or reversing disease conditions.
Assistance in managing and monitoring drug therapy for patients receiving treatment for cancer or chronic conditions such as asthma and diabetes, consulting with patients and their families on the proper use of medication; conducting wellness and disease prevention programs to improve public health; overseeing medication use in a variety of settings.
Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...
Complementary and Alternative Medicine
Alternative medicine are whole medical systems that did not fit with conventional medicine as they have completely different philosophies and ideas on the causes of disease, methods of diagnosis and approaches to treatment. Although often overlapping, co...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...