Assessing the Effects of ELO Water on Diabetic Foot Ulcers

NCT05908968 | Completed

• 1 other identifier: ELO DFU
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Reduction in wound area

  Absolute and percentage reduction in wound area

  12 weeks

Secondary Outcomes (1)

• Complete wound closure

  12 weeks

Study Arms (1)

Drinking ELO water

EXPERIMENTAL

Drinking 1.5 litres of ELO water daily

Dietary Supplement: ELO water

Interventions

ELO water DIETARY_SUPPLEMENT

Drinking 1.5 litres daily of ELO water for 12 weeks

Drinking ELO water

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changi General Hospital: lead
• ELO Water Pte. Ltd.: collaborator

Study Sites (1)

Joan Khoo

Singapore, 529889, Singapore

Location

Related Publications (3)

• 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.

  PMID: 20394633 RESULT

• 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.

  PMID: 35510518 RESULT

• 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 adjuvant therapy for type 2 diabetes in a randomized placebo-controlled trial. PLoS One. 2021 Jul 14;16(7):e0254619. doi: 10.1371/journal.pone.0254619. eCollection 2021.

  PMID: 34260650 RESULT

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Joan Khoo

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 18, 2023
• Study Start: September 19, 2017
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2021
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)