An interventional study of Melatonin and Hydrogel in Pressure Ulcer, sponsored by Fundacion Rioja Salud. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Fundacion Rioja Salud · Not applicable, Interventional, and Treatment
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.
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 2.0 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 2.0 scale. Survival curves will be used to check possible differences in the follow-up time until epithelization.
526 studies on the registry are indexed under Pressure Ulcer; 120 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 401 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Fundacion Rioja Salud is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Ulcers will be treated daily with melatonin cream for 8 weeks
Drug: Melatonin
Ulcers will be treated daily with hydrogel for 8 weeks
Drug: Hydrogel
Epithelialisation
Percentage of completely epithelialized ulcers
Time frame: Up to 8 weeks
Pressure ulcer area
Percentage of reduction in pressure ulcer area
Time frame: Up to 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Jun 2025, 9 months later.
Of 181 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 9 months is below that.
Counting every sponsor, half of 211 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin