## Protocol Section
### Identification Module
**NCT ID:** NCT06421454

**Brief Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

**Official Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

#### Organization Study ID Info
**ID:** PHM-2021-001
#### Organization
**Class:** OTHER
**Full Name:** Fundacion Rioja Salud
### Status Module
#### Completion Date
**Date:** 2025-11-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Pharmamel S.L.

**Class:** OTHER

**Name:** Universidad de Granada

**Class:** OTHER_GOV

**Name:** Instituto de Salud Carlos III

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundacion Rioja Salud

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Pressure Ulcer

**Keywords:**

- melatonin, ischemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ulcers will be treated daily with melatonin cream for 8 weeks

**Intervention Names:**

- Drug: Melatonin

**Label:** Melatonin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Ulcers will be treated daily with hydrogel for 8 weeks

**Intervention Names:**

- Drug: Hydrogel

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Melatonin

**Description:** Pressure Ulcer will be treated with a melatonin cream daily

**Name:** Melatonin

**Other Names:**

- Mel13Rx

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** Pressure ulcer will be treated with hydrogel daily as a comparator

**Name:** Hydrogel

**Other Names:**

- Intransite

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of completely epithelialized ulcers

**Measure:** Epithelialisation

**Time Frame:** Up to 8 weeks

#### Secondary Outcomes

**Description:** Percentage of reduction in pressure ulcer area

**Measure:** Pressure ulcer area

**Time Frame:** Up to 8 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marco.aldonza.torres@navarra.es

**Name:** Marco Aldonza-Torres

**Phone:** +34 848 4229505

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fundacion Rioja Salud

**Name:** Marco Aldonza -Torres

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Ulcer

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcer

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000014456

- Term: Ulcer

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000002492

- Term: Central Nervous System Depressants

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M11533

- Name: Melatonin

- Relevance: HIGH

- As Found: Profile

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T410

- Name: Melatonin

- Relevance: HIGH

- As Found: Profile

### Intervention Browse Module - Meshes

- ID: D000008550

- Term: Melatonin

### Misc Info Module

- Version Holder: 2024-05-31
