A single arm open label clinical study to evaluate safety of GelX V1.0
Research type
Research Study
Full title
A single arm open label clinical study to evaluate safety of GelX anti-microbial, anti-biofilm topical wound care product on non-healing Venous Leg Ulcers.
IRAS ID
245085
Contact name
Jeanette Milne
Contact email
Sponsor organisation
Medtrade Products Ltd
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
The study intends to confirm the safety of GelX when deployed according to its directions for use as a primary wound dressing in venous ulcers with delayed healing. Studies documenting the safety profile of a medical device are essential in the early stages of its development and are a pre-requisite to further testing to quantify efficacy or effectiveness. Participants with venous leg ulcers have been selected as the study population because they constitute a significant proportion among individuals with chronic wounds in the United Kingdom. Among them, those with delayed healing have been deemed appropriate for the study because there is evidence that these cases are mostly due to long standing wound infection which the device has been demonstrated in vitro to disrupt.
The study intends to recruit a total of thirty (30) eligible participants from up to three (3) sites. Potential subjects would be identified and screened for eligibility via their medical case notes. During routine treatment, eligible individuals would be provided information about the study and given the opportunity to enrol. A maximum treatment period of four (4) weeks is planned, followed by two (2) weeks of observation under standard care. Participants would need to have dressings changed every three (3) days while follow-up visits with the research team would be once a week. During follow-up visits, reports on adverse events and a full assessment of the wound and peri-wound skin (including wound photographs) would be recorded. The presence or absence of infection would be confirmed by voluntary consented tissue sampling at baseline and after 4 weeks treatment. A quality of life questionnaire (Wound-QoL) would also be filled at these visits (baseline, week 4).
The extended two week period of observation after stopping treatment is to document any delayed adverse events and/or continued benefits of GelX treatment.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0310
Date of REC Opinion
23 Nov 2018
REC opinion
Further Information Favourable Opinion