21.Jul.2012

Medical device clinical study completion in Lithuania

In July 2012 OCT-ClinicalTrials in Central and Eastern Europe successfully closed two sites in Lithuania, Baltic States, participating in the clinical research of the medical device for wound healing.

In July 2012 OCT-ClinicalTrials in Central and Eastern Europe successfully closed two sites in Lithuania, Baltic States, participating in the clinical research of the medical device for wound healing. The clinical monitoring activities have been outsourced to OCT from the leading European contract research organization. The project is the result of effective collaboration between two CROs covering different regions – Eastern and Western Europe, and reflects the repeat business. Two additional sites are to be closed by OCT by the phone as well according to the new request of the Client.

That was a Phase III randomized, sham-controlled, parallel-group, multicenter, group-sequential trial to evaluate the safety and efficacy of the device (namely multi-layer compression bandage) to promote healing in the treatment of venous ulcers of the lower extremity.

The investigational product is intended to provide an unmet medical need in subjects with unhealed venous ulcers. In conjunction with the current standard of care (compression bandages and counseling to elevate the leg and remain active), the tested product as a Class II (US) and Class IIa (EU) medical device is being studied to assess the safety and effectiveness of the delivery system. The investigational product is designed to offer medical professionals a proven, uniform and reproducible device which enhances the effectiveness of conventional compression using ambulatory electrotherapy and subject compliance and monitoring features. The delivery system, combining several approaches, may be effective in this non-healing subject population that is non-responsive to compression alone.

Upon the completion of the clinical study, the following activities have been conducted by OCT’s monitor in conjunction with the investigators: return of all study data to the Sponsor; data clarifications and/or resolutions; accounting, reconciliation, and final disposition of used and unused devices; review of site study records for completeness.

OCT’s Baltic CRA was responsible for SCOV preparation, conduct, reporting and follow-up. Most of the activities of the CRA were connected with monitoring outstanding CRFs.

Due to the agreements with the Client, study close-out notification and study report will be submitted to the Lithuanian Regulatory Authorities and EC by the Sponsor itself.

Study termination and follow-up are conducted in compliance with the international, national, and/or local laws and guidelines, Sponsor’s and OCT’s SOPs.

It has been estimated that 600,000 individuals are affected by venous ulcers in the United States alone. Lower extremity ulcers associated with venous insufficiency have been estimated to affect 1% to 2% of the population in developing countries and affect more than 1% of those over 60 years of age. As a result, chronic wounds of the dermal tissue present a significant public health problem that accounts for as much as two billion dollars in health care costs annually. Cost estimates in Europe range from approximately 1% - 2% of the national health care budget. The major costs involved in the treatment of chronic venous ulcers have been reported to result from hospitalizations, home health care and dressing changes. Chronic venous ulcers arise from a number of disease states and risk factors, including diabetic neuropathy, cardiovascular ischemia, and a history of deep vein thrombosis (DVT), sickle cell disease, soft tissue impairments, vascular insufficiency and even pregnancy.

Venous ulcers are associated with a state of venous insufficiency. Venous ulcers tend to remain unhealed for many years. The complications of chronic open wounds are potentially disabling and include infections (cellulitis, sepsis, and osteomyelitis), chronic pain, impaired ability to ambulate, and in the worst case, amputation. Even in the absence of progressive disability, chronic venous ulcers tend to be resistant to treatment and frequently recur after successful therapy. It has been reported that approximately 16% of venous ulcers recur even after complete healing.