Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Dietary Supplement: ELO water

• Registration Number: NCT05908968
• Lead Sponsor: Changi General Hospital

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.

Study Timeline

• Study Start: 2017-09-19
• Primary Completion: 2019-11-30
• Study Completion: 2021-06-30
• Status Verified: 2023-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drinking ELO water	ELO water	Drinking 1.5 litres of ELO water daily

Primary Outcome Measures

Name	Time	Method
Reduction in wound area	12 weeks	Absolute and percentage reduction in wound area

Secondary Outcome Measures

Name	Time	Method
Complete wound closure	12 weeks	Percentage of wounds with complete closure

Trial Locations

Locations (1)

Joan Khoo; 🇸🇬 Singapore, Singapore