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

NCT06421454 | Not Yet Recruiting

• 1 other identifier: PHM-2021-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pressure Ulcer

Keywords

melatonin, ischemia

Outcome Measures

Primary Outcomes (1)

• Epithelialisation

  Percentage of completely epithelialized ulcers

  Up to 8 weeks

Secondary Outcomes (1)

• Pressure ulcer area

  Up to 8 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

Ulcers will be treated daily with melatonin cream for 8 weeks

Drug: Melatonin

Control

ACTIVE COMPARATOR

Ulcers will be treated daily with hydrogel for 8 weeks

Drug: Hydrogel

Interventions

Melatonin DRUG

Pressure Ulcer will be treated with a melatonin cream daily

Also known as: Mel13Rx

Melatonin

Hydrogel DRUG

Pressure ulcer will be treated with hydrogel daily as a comparator

Also known as: Intransite

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Rioja Salud: lead
• Pharmamel S.L.: collaborator
• Universidad de Granada: collaborator
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Pressure Ulcer; Ischemia

Interventions

Melatonin; Hydrogels

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marco Aldonza -Torres

  Fundacion Rioja Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Aldonza-Torres

CONTACT

+34 848 4229505; marco.aldonza.torres@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: May 20, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share