Injuries and WoundsPhase 1/2ALOENCT02819817
A Trial of Topical Aloe Vera Gel in Emergency Department Patients Presenting With Simple Traumatic Wounds
A Phase 1/2 study testing Aloe Vera Gel and Ultrasound gel in people with Injuries and Wounds, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Injuries and Wounds
- What is being tested?
- Aloe Vera Gel and Ultrasound gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2017to Feb 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Known allergy to either Aloe Vera or ultrasound gel
- Patients under 16 year of age
- No telephone number for follow-up
- Patient lacking capacity
- Patient currently using antibiotics
- Patient having a puncture or bite wound
Show all 16Show fewer
- Patient having underlying tendon or bone involvement or wound overlying a joint
- Patients with burn wounds
- Wounds more than 24 hours old
- Patient unable/unwilling to attend follow-up
- Patients unable to self administer treatment.
- Wound that treating clinician would not routinely dress e.g. facial wounds (face, ear, eyebrow, nose, lip, eyelid, scalp), mucosa and hair covered areas, or wounds that require specialist dressing
- Self reported pregnancy
- Patients with a known allergy to the study dressing
- Patients currently recruited in another clinical trial
- Patients already recruited in the ALOE Study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
Official title: A Parallel Group Double Blind Placebo Randomised Controlled Trial (RCT) of Topical Aloe Vera Gel in Emergency Department (ED) Patients Presenting With Simple Traumatic Wounds
This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.
Read the detailed description
Simple traumatic wounds are a common presenting symptom to the 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.
- Conditions
- Injuries and Wounds
- Being tested
- Aloe Vera Gel, Ultrasound gel
- Keywords
- Aloe Vera, wound, healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Vera GelDrug
Also called Aloe Vera Gel (LIFEPLAN)
The participant 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.
Ultrasound gelOther
Also called Sterile (AQUASONIC 100) ultrasound transmission gel
The participant 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.
| Study group | Role | What they receive |
|---|---|---|
| Aloe Vera Gel | Experimental | Experimental gel placed in identical opaque tube as placebo gel. Receives: Drug: Aloe Vera Gel |
| Ultrasound Gel | Placebo comparator | Placebo placed in identical opaque tube as experimental gel. Receives: Other: Ultrasound gel |
| Standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)
Measured: Day 21 (+/- 2 days)
Secondary outcomes (6)
Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)
Measured: Baseline and day 10 (+/- 2 days)
Size (width and height in mm) of wound at baseline, day 10 (+/- 2 days), and day 21 (+/- 2 days)
Measured: Baseline, day 10 (+/- 2 days) and day 21 (+/- 2 days)
Characteristics (visibility of wound edges and leakage from wound) as reported by participant at day 21 (+/- 2 days)
Measured: Day 21 (+/- 2 days)
Wound infection rate
Measured: Day 21 (+/- 2 days)
Participant satisfaction score
Measured: Day 21 (+/- 2 days)
Participant treatment compliance (i.e. the total weight of gel used)
Measured: Day 10 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startApr 2017 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Why it stopped: MHRA CTA rejected due to no UK MHRA MA certificate or equivalent product info
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries and WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Matthew J Reed, MA FRCEM MD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819817
- Sponsor's protocol ID
- AC16063
- Acronym
- ALOE
- Status last verified
- Feb 2017
- First submitted
- 28 Jun 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group Double Blind Placebo Randomised Controlled Trial (RCT) of Topical Aloe Vera Gel in Emergency Department (ED) Patients Presenting With Simple Traumatic Wounds
- ClinicalTrials.gov ID
- NCT02819817
- Acronym / sponsor ID
- ALOE / AC16063
- Conditions
- Injuries and Wounds
- Keywords
- Aloe Vera, wound, healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: MHRA CTA rejected due to no UK MHRA MA certificate or equivalent product info
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- University of Edinburgh
- Study start
- Apr 2017 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.
Detailed description
Simple traumatic wounds are a common presenting symptom to the 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera Gel | Experimental | Drug: Aloe Vera GelExperimental gel placed in identical opaque tube as placebo gel. |
| Ultrasound Gel | Placebo comparator | Other: Ultrasound gelPlacebo placed in identical opaque tube as experimental gel. |
| Standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Known allergy to either Aloe Vera or ultrasound gel
- Patients under 16 year of age
- No telephone number for follow-up
- Patient lacking capacity
- Patient currently using antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe Vera GelAlso: Aloe Vera Gel (LIFEPLAN)The participant 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. | Drug | Aloe Vera Gel |
| Ultrasound gelAlso: Sterile (AQUASONIC 100) ultrasound transmission gelThe participant 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. | Other | Ultrasound Gel |
Primary outcome
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)
Time frame: Day 21 (+/- 2 days)
6 secondary outcomes
Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)
Time frame: Baseline and day 10 (+/- 2 days)
Size (width and height in mm) of wound at baseline, day 10 (+/- 2 days), and day 21 (+/- 2 days)
Time frame: Baseline, day 10 (+/- 2 days) and day 21 (+/- 2 days)
Characteristics (visibility of wound edges and leakage from wound) as reported by participant at day 21 (+/- 2 days)
Time frame: Day 21 (+/- 2 days)
Wound infection rate
Time frame: Day 21 (+/- 2 days)
Participant satisfaction score
Time frame: Day 21 (+/- 2 days)
Participant treatment compliance (i.e. the total weight of gel used)
Time frame: Day 10 (+/- 2 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Reed, MA FRCEM MD principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aloe Vera Gel and Ultrasound gel in people with Injuries and Wounds, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation) (time frame: Day 21 (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.