The ALOE Study
Research type
Research Study
Full title
A double blind randomised controlled trial of topical Aloe Vera Gel versus Placebo, and topical Aloe Vera Gel versus standard care in Emergency Department patients presenting with simple traumatic wounds (The ALOE study)
IRAS ID
190329
Contact name
Matthew Reed
Contact email
Eudract number
2016-002717-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Simple traumatic wounds are a common presentation to the Emergency Department (ED) affecting thousands of patients worldwide every day. Aloe Vera is a natural product that has been linked to better healing both anecdotally and in animal studies. A recent Cochrane review failed to find any human studies on acute wounds such as those seen in the ED. The aim of this study is to see whether Aloe Vera gel improves the wound healing time in these patients. We plan to enrol 270 participants presenting to the Royal Infirmary of Edinburgh ED with simple traumatic wounds into a randomised controlled trial. Participants will be assessed at baseline using the Bates-Jensen wound assessment tool. They will be then be randomized to one of three groups, and allocated to receive either Aloe Vera gel, control (Ultrasound gel) or standard care. The participants in the two gel groups will have identical packaging and the treating clinician will be unaware as to which group they are allocated. They will be asked to place the allocated substance onto the wound twice daily and cover with a supplied dressing on each occasion for 1 week. All groups will be asked to return to the ED for a repeat Bates-Jensen wound assessment, and will also be asked to record the number of days that their wound took to heal. The gel groups will have assessment of product usage. Participants will also be telephoned at 3 weeks. Primary outcome will be number of days for wound to heal. Secondary outcome will be change in Bates-Jensen wound assessment score between baseline and day 10, change in wound size between baseline and day 10 and baseline and day 21, changes in wound characteristics at day 21 as reported by participants, wound infection rate, participant satisfaction and participant compliance with treatment.
REC name
West of Scotland REC 1
REC reference
16/WS/0163
Date of REC Opinion
5 Oct 2016
REC opinion
Further Information Favourable Opinion