Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

Pressure Ulcer Clinical Trial

Official title:

Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421454
• Other study ID #: PHM-2021-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Fundacion Rioja Salud
• Contact: Marco Aldonza-Torres
• Phone: +34 848 4229505
• Email: marco.aldonza.torres[@]navarra.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Present at least one category II, III or IV pressure ulcer according to National Group for the Study and Assessment of Pressure Ulcers (GNEAUPP) classification.
• Ulcer area between 1 and 100 cm2.
• People over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian

Exclusion Criteria:

• Ulcer of category I, non-classifiable or affecting internal tissues, but with no break in the skin
• People currently undergoing chemotherapy treatment or who have done so in the previous 6 months
• People with a presumed life expectancy of less than 6 months or in palliative care.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Drug:
• Melatonin
Pressure Ulcer will be treated with a melatonin cream daily
• Hydrogel
Pressure ulcer will be treated with hydrogel daily as a comparator

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Fundacion Rioja Salud	Instituto de Salud Carlos III, Pharmamel S.L., Universidad de Granada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelialisation	Percentage of completely epithelialized ulcers	Up to 8 weeks
Secondary	Pressure ulcer area	Percentage of reduction in pressure ulcer area	Up to 8 weeks