Assessing the Effects of ELO Water on Diabetic Foot Ulcers

Sponsor

Changi General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05908968

Collaborator

ELO Water Pte. Ltd. (Industry)

Enrollment

Location

Arm

45.3

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Foot Ulcer, Diabetic	Dietary Supplement: ELO water	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 recruitmentAdults 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 19, 2017

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drinking ELO water Drinking 1.5 litres of ELO water daily	Dietary Supplement: ELO water Drinking 1.5 litres daily of ELO water for 12 weeks

Arm

Intervention/Treatment

Experimental: Drinking ELO water

Drinking 1.5 litres of ELO water daily

Dietary Supplement: ELO water

Drinking 1.5 litres daily of ELO water for 12 weeks

Outcome Measures

Primary Outcome Measures

Reduction in wound area [12 weeks]
Absolute and percentage reduction in wound area

Secondary Outcome Measures

Complete wound closure [12 weeks]
Percentage of wounds with complete closure

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joan Khoo	Singapore		Singapore	529889

Sponsors and Collaborators

Changi General Hospital
ELO Water Pte. Ltd.

Investigators

Principal Investigator: Joan Khoo, Changi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changi General Hospital

ClinicalTrials.gov Identifier:

NCT05908968

Other Study ID Numbers:

ELO DFU

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Ulcer

Study Results

No Results Posted as of Jun 18, 2023