A Phase II, Randomised, Double Blind, Placebo Controlled Study examining the suitability of Phenytoin Sodium Topical Gel in the treatement of Venous Ulcers

Royal College of Surgeon's Ireland0 sitesSeptember 5, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 5, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Royal College of Surgeon's Ireland

•Eligible subjects MUST comply with the following criteria:
•1\. Subject must have a venous ulcer in the lower leg with a surface area of at least 5cm2 (as indicated by clinical signs and symptoms of venous ulceration, such as hyperpigmentation of surrounding skin, varicosities, and lipodermatosclerosis).
•2\. Subject must be more than 18 years old.
•3\. Absence of significant arterial insufficiency in the affected limb (indicated by an ankle\-brachial index of \>0\.70\).
•4\. Evidence of venous insufficiency on Doppler.
•5\. Wound must be free of eschar and obvious necrotic tissue.
•6\. Wounds must be free from cellulites and exudation indicative of heavy bacterial contamination (treatment of bacterial infections with antibiotics prior to commencement is permitted).
•7\.Provision of a written informed consent prior to enrolment.
•8\.Agree to avoid pregnancy and not to nurse a child throughout the study (females of child\-bearing potential)
•9\.All females of child bearing potential must have a negative pregnancy test at the Screening Visit and agree to practice a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilised

•Eligible subjects MUST NOT:
•1\. Have clinical signs of cellulites.
•2\. Have clinical signs or history of vasculitis.
•3\. Have clinical signs or history of collagen vascular diseases.
•4\. Be pregnant or lactating.
•5\. Have a history of rheumatoid arthritis.
•6\. Have sickle cell anaemia.
•7\. Have uncontrolled diabetes mellitus (subjects with well\-controlled diabetes mellitus will be included).
•8\. Have other clinically significant medical conditions that would impair wound healing, inclusive of renal, hepatic, haematological, neurological, or immunological disease or poor nutritional status (albumin \<30g/l).
•9\. Be receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within one month prior to entry into the study.