TOVU
Research type
Research Study
Full title
Evaluating the role of topical oxygenation in the healing of venous leg ulcers
IRAS ID
221420
Contact name
Ayoola Awopetu
Contact email
Sponsor organisation
Inotec AMD
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Chronic wounds are those that persist for longer than three months and do not follow the defined process of normal healing. Venous leg ulcers (VLU) are the most common type of chronic wounds. Approximately 1% in the general population and 4% in the age group over the age of 65 are affected by VLU. Chronic VLU that fail to heal can cause significant expense to the National Health Service, as well as having a huge impact on the quality of life of sufferers. Ultimately, they place their sufferers at risk of experiencing a major limb amputation.
Although, most these wounds are managed in the outpatient setting, the treatment presents a clinical conundrum as the regime can be both expensive and is associated with high rates of recurrence. Most importantly however is that patients have a high dissatisfaction with the current treatments available.
Tissue oxygenation plays a vital role in the healing process. It contributes to the different microscopic processes involved in wound healing. Many wounds fail to heal because of low oxygen levels in the tissues. Most leg ulcers occur in elderly patients, and many of these have an underlying problem that slows down or restricts the transfer of oxygen from the lungs to the wound tissue. The Natrox™ system is a device designed to deliver continuous oxygen to the wound bed through a standard dressing.
This is a study aiming to evaluate the Natrox™ system on the healing of chronic VLU. This study will investigate the effect continuous oxygen has on the reduction of the size of the wound, as well as examining how the biological environment of the wound changes after its use, when compared to standard treatment.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0236
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion