Foot Ulcer, DiabeticNCT05908968
Assessing the Effects of ELO Water on Diabetic Foot Ulcers
A study testing ELO water in people with Foot Ulcer, Diabetic, run by Changi General Hospital at 1 site in Singapore.
Trial summary
This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- ELO water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Sep 2017to 30 Jun 2021
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes and haemoglobin A1c (HbA1c) at screening of 7.0-10.0% on oral glucose-lowering medication and/or insulin at a stable dose for the last three months
Who cannot join
- pregnant or lactating
- conditions which would independently worsen ulcer healing such as severe peripheral vascular disease or varicose veins
- immunosuppressive therapy
- comorbidities necessitating fluid restriction such as renal, liver or cardiac failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Effects of Oxygen-enriched Water (ELO Water) on Wound Healing for Diabetic Foot Ulcers
This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.
Read the detailed description
As hyperbaric chamber and topical oxygen therapies have demonstrated efficacy in improving DFU healing, the aim of this study was to evaluate ELO water, which has been shown to increase arterial oxygen levels, as a novel means of increasing oxygen delivery to poorly-healing DFUs as an adjunct to standard care. This proof-of-concept pilot study of drinking oxygen-enriched ELO water to treat diabetic foot ulcers (DFUs) was conducted on 16 adults with non-healing (for at least 30 days prior to the study) DFUs in Changi General Hospital in Singapore.
ELO water was delivered to participants' homes and their water consumption recorded in diaries, which was checked by the research co-ordinator at 2-weekly visits for 12 weeks. Minimum compliance was defined to be at least 85% of the water (12/14 bottles/fortnight), equivalent to 9 litres/week. No changes in diabetic therapy, diet or exercise were made during the study period.
All participants were seen by podiatrist for standard of care DFU treatment weekly. The ulcer size was captured following wound debridement each week using a standardized digital photographic protocol and the photos were encrypted and anonymized for confidentiality and data protection. All the images were assessed independently. Wound dressing was carried out twice per week in between visits at primary care clinics or at home.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- ELO water
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELO waterDietary supplement
Drinking 1.5 litres daily of ELO water for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drinking ELO water | Experimental | Drinking 1.5 litres of ELO water daily Receives: Dietary Supplement: ELO water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in wound area
Absolute and percentage reduction in wound area
Measured: 12 weeks
Secondary outcomes (1)
Complete wound closure
Percentage of wounds with complete closure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start19 Sep 2017
- Primary completion30 Nov 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adults with type 2 diabetes and diabetic foot ulcer which has not healed with conventional therapy for at least 30 days prior to recruitment
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ELO Water Pte. Ltd.
- Responsible party
- Sponsor
- Investigators
- Joan Khoo, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908968
- Sponsor's protocol ID
- ELO DFU
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schreml S, Szeimies RM, Prantl L, Karrer S, Landthaler M, Babilas P. Oxygen in acute and chronic wound healing. Br J Dermatol. 2010 Aug;163(2):257-68. doi: 10.1111/j.1365-2133.2010.09804.x. Epub 2010 Apr 15.
PubMed 20394633Sun XK, Li R, Yang XL, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J. 2022 Dec;19(8):2200-2209. doi: 10.1111/iwj.13830. Epub 2022 May 5.
PubMed 35510518Khoo J, Hagemeyer CE, Henstridge DC, Kumble S, Wang TY, Xu R, Gani L, King T, Soh SB, Puar T, Au V, Tan E, Tay TL, Kam C, Teo EK. Effects of water stably-enriched with oxygen as a novel method of tissue oxygenation on mitochondrial function, and as adjuvant therapy for type 2 diabetes in a randomized placebo-controlled trial. PLoS One. 2021 Jul 14;16(7):e0254619. doi: 10.1371/journal.pone.0254619. eCollection 2021.
PubMed 34260650
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Oxygen-enriched Water (ELO Water) on Wound Healing for Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05908968
- Acronym / sponsor ID
- ELO DFU
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- ELO Water Pte. Ltd.
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Jun 2023 (actual)
- 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 pilot study examined the effects of ELO water, a commercially-available oxygen-enriched drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.
Detailed description
As hyperbaric chamber and topical oxygen therapies have demonstrated efficacy in improving DFU healing, the aim of this study was to evaluate ELO water, which has been shown to increase arterial oxygen levels, as a novel means of increasing oxygen delivery to poorly-healing DFUs as an adjunct to standard care. This proof-of-concept pilot study of drinking oxygen-enriched ELO water to treat diabetic foot ulcers (DFUs) was conducted on 16 adults with non-healing (for at least 30 days prior to the study) DFUs in Changi General Hospital in Singapore.
ELO water was delivered to participants' homes and their water consumption recorded in diaries, which was checked by the research co-ordinator at 2-weekly visits for 12 weeks. Minimum compliance was defined to be at least 85% of the water (12/14 bottles/fortnight), equivalent to 9 litres/week. No changes in diabetic therapy, diet or exercise were made during the study period.
All participants were seen by podiatrist for standard of care DFU treatment weekly. The ulcer size was captured following wound debridement each week using a standardized digital photographic protocol and the photos were encrypted and anonymized for confidentiality and data protection. All the images were assessed independently. Wound dressing was carried out twice per week in between visits at primary care clinics or at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adults with type 2 diabetes and diabetic foot ulcer which has not healed with conventional therapy for at least 30 days prior to recruitment
| Arm | Type | Receives |
|---|---|---|
| Drinking ELO water | Experimental | Dietary Supplement: ELO waterDrinking 1.5 litres of ELO water daily |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes and haemoglobin A1c (HbA1c) at screening of 7.0-10.0% on oral glucose-lowering medication and/or insulin at a stable dose for the last three months
Key exclusion criteria (4 listed)
- pregnant or lactating
- conditions which would independently worsen ulcer healing such as severe peripheral vascular disease or varicose veins
- immunosuppressive therapy
- comorbidities necessitating fluid restriction such as renal, liver or cardiac failure.
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 |
|---|---|---|
| ELO waterDrinking 1.5 litres daily of ELO water for 12 weeks | Dietary supplement | Drinking ELO water |
Primary outcome
Reduction in wound area
Time frame: 12 weeks
Absolute and percentage reduction in wound area
1 secondary outcome
Complete wound closure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Results publication: PubMed 20394633Schreml S, Szeimies RM, Prantl L, Karrer S, Landthaler M, Babilas P. Oxygen in acute and chronic wound healing. Br J Dermatol. 2010 Aug;163(2):257-68. doi: 10.1111/j.1365-2133.2010.09804.x. Epub 2010 Apr 15.
- Results publication: PubMed 35510518Sun XK, Li R, Yang XL, Yuan L. Efficacy and safety of topical oxygen therapy for diabetic foot ulcers: An updated systematic review and meta-analysis. Int Wound J. 2022 Dec;19(8):2200-2209. doi: 10.1111/iwj.13830. Epub 2022 May 5.
- Results publication: PubMed 34260650Khoo J, Hagemeyer CE, Henstridge DC, Kumble S, Wang TY, Xu R, Gani L, King T, Soh SB, Puar T, Au V, Tan E, Tay TL, Kam C, Teo EK. Effects of water stably-enriched with oxygen as a novel method of tissue oxygenation on mitochondrial function, and as adjuvant therapy for type 2 diabetes in a randomized placebo-controlled trial. PLoS One. 2021 Jul 14;16(7):e0254619. doi: 10.1371/journal.pone.0254619. eCollection 2021.
- 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.
Joan Khoo principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELO water in people with Foot Ulcer, Diabetic, run by Changi General Hospital at 1 site in Singapore.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2023. 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 Singapore. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in wound area (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908968, which also lists 3 linked publications.
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 18 Jun 2023.