Assessing the Effects of ELO Water on Diabetic Foot Ulcers
Primary Purpose
Foot Ulcer, Diabetic
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
ELO water
Sponsored by
About this trial
This is an interventional treatment trial for Foot Ulcer, Diabetic
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Joan Khoo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drinking ELO water
Arm Description
Drinking 1.5 litres of ELO water daily
Outcomes
Primary Outcome Measures
Reduction in wound area
Absolute and percentage reduction in wound area
Secondary Outcome Measures
Complete wound closure
Percentage of wounds with complete closure
Full Information
NCT ID
NCT05908968
First Posted
June 4, 2023
Last Updated
June 16, 2023
Sponsor
Changi General Hospital
Collaborators
ELO Water Pte. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05908968
Brief Title
Assessing the Effects of ELO Water on Diabetic Foot Ulcers
Official Title
A Pilot Study to Assess the Effects of Oxygen-enriched Water (ELO Water) on Wound Healing for Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
Collaborators
ELO Water Pte. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drinking ELO water
Arm Type
Experimental
Arm Description
Drinking 1.5 litres of ELO water daily
Intervention Type
Dietary Supplement
Intervention Name(s)
ELO water
Intervention Description
Drinking 1.5 litres daily of ELO water for 12 weeks
Primary Outcome Measure Information:
Title
Reduction in wound area
Description
Absolute and percentage reduction in wound area
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Complete wound closure
Description
Percentage of wounds with complete closure
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Khoo
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joan Khoo
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20394633
Citation
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.
Results Reference
result
PubMed Identifier
35510518
Citation
Sun 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 Reference
result
PubMed Identifier
34260650
Citation
Khoo 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.
Results Reference
result
Learn more about this trial
Assessing the Effects of ELO Water on Diabetic Foot Ulcers
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