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
Verified date | June 2023 |
Source | Changi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Joan Khoo | Singapore |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital | ELO Water Pte. Ltd. |
Singapore,
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
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 |
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