The GORE® VIAFORT Vascular Stent IVC Study
Venous ThrombosesVenous Disease8 moreThis study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
Venous Leg UlcerThe purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg ulcer .
Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous...
Venous Leg UlcerThis project adopts a prospective clinical trial study to compare and evaluate the efficacy of local transplantation of human umbilical cord mesenchymal stem cells combined with silver ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer wounds. To improve the healing rate and quality of life of patients.
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Varicose UlcerThe objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers...
Wound HealApproximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center...
Diabetic Foot UlcerVenous Leg Ulcer2 moreProspective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care...
Diabetic Foot UlcerVenous Leg UlcerIn participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring
Wound CarePressure Ulcer4 moreThis study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with IDRT without burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.
DEep VEin Lesion OPtimisation (DEVELOP) Trial
Venous Leg UlcerThis is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.
The Impact of a Pluridisciplinary Education Program on Venous Leg Ulcer Size Reduction
Patient EmpowermentVenous Leg Ulcer1 moreBackground and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate of 70% and a 60% risk of becoming chronic. The estimated VLU prevalence in the general population is 3%. Current therapeutic approaches are multifaceted and focus on reducing wound size and improving wound healing as well as preventing ulcer recurrence. They require a pluridisciplinary team of health care professionals from the domains of nursing, medicine, physiotherapy and nutrition. Approximately 70% of VLU patients have a knowledge deficit in regards to therapeutic measures and have difficulties with adherence to treatment protocols. However, there are no published studies describing and evaluating the impact of pluridisciplinary educational interventions on adherence to the treatment plan and wound size reduction in VLU patients. Overall objectives: The objectives of the projected study are to evaluate the effectiveness of nurse-led intervention for high-risk patients with VLU in terms of patient knowledge/therapy adherence and to measure the impact of this intervention on wound size reduction and its evolution over time. Methodology of the planned study: An international multicenter randomized controlled trial with 248 participants in three Swiss French (n= 124) and two Australian (n=124) wound clinics is proposed. The sample size assumptions are based on a two-sided alpha level of 0.05, power of 0.8, and a medium effect size. Univariate and bivariate analysis will be conducted according to the data level and distribution. Expected results and impact: The findings of this study will generate new knowledge and the results will contribute to VLU clinical practice guidelines to enhance patient adherence to therapy. Our results will not only help improving patients' quality of life, but also contribute to reducing health expenditure.