Pressure UlcerNCT06421454
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
A study testing Melatonin and Hydrogel in people with Pressure Ulcer, run by Fundacion Rioja Salud.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Melatonin and Hydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Pressure Ulcer
- Being tested
- Melatonin, Hydrogel
- Keywords
- melatonin, ischemia
- Medical subject headings
- Pressure Ulcer, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Mel13Rx
Pressure Ulcer will be treated with a melatonin cream daily
HydrogelDrug
Also called Intransite
Pressure ulcer will be treated with hydrogel daily as a comparator
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Ulcers will be treated daily with melatonin cream for 8 weeks Receives: Drug: Melatonin |
| Control | Active comparator | Ulcers will be treated daily with hydrogel for 8 weeks Receives: Drug: Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialisation
Percentage of completely epithelialized ulcers
Measured: Up to 8 weeks
Secondary outcomes (1)
Pressure ulcer area
Percentage of reduction in pressure ulcer area
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Rioja Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmamel S.L., Universidad de Granada, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Marco Aldonza -Torres, Principal investigator, Fundacion Rioja Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421454
- Sponsor's protocol ID
- PHM-2021-001
- Status last verified
- May 2024
- First submitted
- 3 Dec 2021
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
- ClinicalTrials.gov ID
- NCT06421454
- Acronym / sponsor ID
- PHM-2021-001
- Conditions
- Pressure Ulcer
- Keywords
- melatonin, ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Rioja SaludUniversity, hospital or other
- Collaborators
- Pharmamel S.L., Universidad de Granada, Instituto de Salud Carlos III
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninUlcers will be treated daily with melatonin cream for 8 weeks |
| Control | Active comparator | Drug: HydrogelUlcers will be treated daily with hydrogel for 8 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Mel13RxPressure Ulcer will be treated with a melatonin cream daily | Drug | Melatonin |
| HydrogelAlso: IntransitePressure ulcer will be treated with hydrogel daily as a comparator | Drug | Control |
Primary outcome
Epithelialisation
Time frame: Up to 8 weeks
Percentage of completely epithelialized ulcers
1 secondary outcome
Pressure ulcer area
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Aldonza -Torres principal investigator
Fundacion Rioja Salud
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Hydrogel in people with Pressure Ulcer, run by Fundacion Rioja Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Aldonza-Torres (+34 848 4229505, marco.aldonza.torres@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelialisation (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.