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

PHM-2021-001

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.

2024-09-01

2025-06-01

2025-11-01

Not yet recruiting

50

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-05-20