Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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

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Foot Ulcer, Diabetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Adults with type 2 diabetes and diabetic foot ulcer which has not healed with conventional therapy for at least 30 days prior to recruitment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drinking ELO water

Drinking 1.5 litres of ELO water daily

Group Type EXPERIMENTAL

ELO water

Intervention Type DIETARY_SUPPLEMENT

Drinking 1.5 litres daily of ELO water for 12 weeks

Interventions

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ELO water

Drinking 1.5 litres daily of ELO water for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No