A prospective, interventional, open label clinical study to evaluate the safety of SIS WOUNDCARE â?? DEVICE for chronic wound healing.

SIS MANUFACTURING LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

试验速览

暂无简介。

•1.Patients with age above 18.
•2.Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
•3.Subject has wound present for more than 30 days despite appropriate wound care
•4.Subject has adequate blood perfusion
•5.Subject is able to understand and provide written consent.

•1.Subject has Active Infection
•2.Subject has Untreated Osteomyelitis
•3.Subject has Allergy to Wound Care Products used in the study
•4.Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
•5.Subject has Active Charcot Arthropathy of the Foot
•6.Subject has study wound location on toes or plantar surface of foot
•7.Subject has uncontrolled hyperglycaemia
•8.Subject has end stage renal disease requiring dialysis
•9.Subject is undergoing active chemotherapy treatment that inhibits wound healing or has identified cancer
•10.Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrolment
•11.Subject has a >30% wound surface area reduction in size at 1 week after screening visit
•12.Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
•13.Subject is unwilling or unable to comply with protocol requirements
•14.Subject is pregnant.

发起方

SIS MANUFACTURING LIMITED