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Completed

NCT Number: NCT05908968

Assessing the Effects of ELO Water on 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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joan Khoo

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELO Water

Dietary Supplement

Drinking 1.5 litres daily of ELO water for 12 weeks

Primary outcomes

  1. Reduction in wound area

    Time frame: 12 weeks

    Absolute and percentage reduction in wound area

Secondary outcomes

  1. Complete wound closure

    Time frame: 12 weeks

    Percentage of wounds with complete closure

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • ELO Water Pte. Ltd.

Registry information

Official study title

A Pilot Study to Assess the Effects of Oxygen-enriched Water (ELO Water) on Wound Healing for Diabetic Foot Ulcers

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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