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

NCT06421454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Pressure Ulcer

Interventions

DRUG

Melatonin

Pressure Ulcer will be treated with a melatonin cream daily

DRUG

Hydrogel

Pressure ulcer will be treated with hydrogel daily as a comparator

Sponsors & Collaborators

  • Pharmamel S.L.

    collaborator INDUSTRY

  • Universidad de Granada

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundacion Rioja Salud

    lead OTHER

Principal Investigators

  • Marco Aldonza -Torres · Fundacion Rioja Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-06-01
Completion
2025-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421454 on ClinicalTrials.gov