Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05908968
• Other study ID #: ELO DFU
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2023
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2021
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Dietary Supplement:
• ELO water
Drinking 1.5 litres daily of ELO water for 12 weeks

Locations

Country	Name	City	State
Singapore	Joan Khoo	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Changi General Hospital	ELO Water Pte. Ltd.

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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 adjuva — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in wound area	Absolute and percentage reduction in wound area	12 weeks
Secondary	Complete wound closure	Percentage of wounds with complete closure	12 weeks