Foot Ulcer, Diabetic
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTELO water
Drinking 1.5 litres daily of ELO water for 12 weeks
Sponsors
ELO Water Pte. Ltd.
Changi General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 recruitment
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in wound area | 12 weeks | Absolute and percentage reduction in wound area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete wound closure | 12 weeks | Percentage of wounds with complete closure |
Countries
Singapore
Outcome results
None listed