Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908968
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-06-04
Brief Title:
Assessing the Effects of ELO Water on Diabetic Foot Ulcers
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
A Pilot Study to Assess the Effects of Oxygen-enriched Water ELO Water on Wound Healing for Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1214 bottlesfortnight equivalent to 9 litresweek 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
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 1214 bottlesfortnight equivalent to 9 litresweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None