Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421454
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2021-12-03
Brief Title:
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
Sponsor:
Fundacion Rioja Salud
Organization:
Fundacion Rioja Salud
Study Overview
Official Title:
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines substances which are present in pressure ulcers and can affect the healing process slowing it down Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy Therefore the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment
Detailed Description:
Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines substances which are present in pressure ulcers and can affect the healing process slowing it down Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy Therefore the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment
In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre single-blind randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks In order to assess the healing rate changes in Resvech 20 scale scores will be measured as well as the ulcer surface reduction To avoid variability in measuring ulcer surface it will be done by using software HELCOS after taking a photograph of the wound weekly An intention-to-treat analysis will be carried out The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 20 scale Survival curves will be used to check possible differences in the follow-up time until epithelization
In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre single-blind randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks In order to assess the healing rate changes in Resvech 20 scale scores will be measured as well as the ulcer surface reduction To avoid variability in measuring ulcer surface it will be done by using software HELCOS after taking a photograph of the wound weekly An intention-to-treat analysis will be carried out The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 20 scale Survival curves will be used to check possible differences in the follow-up time until epithelization
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?:
False
Is an FDA AA801 Violation?:
None