## Protocol Section
### Identification Module
**NCT ID:** NCT06427889

**Brief Title:** Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes

**Official Title:** A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants With a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons With Diabetes

#### Organization Study ID Info
**ID:** 2022-500907-27-01
#### Organization
**Class:** OTHER
**Full Name:** Malmö University
### Status Module
#### Completion Date
**Date:** 2026-08-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Malmö University

#### Responsible Party

**Investigator Affiliation:** Malmö University

**Investigator Full Name:** Tautgirdas Ruzgas

**Investigator Title:** Professor,Biomedical technology, Study director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

- Skin and Connective Tissue Diseases

**Keywords:**

- Diabetes Mellitus

- Dry Skin

- Self Care

- Dry Feet

- Prevention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 98

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Topical on feet twice a day

**Intervention Names:**

- Drug: Canoderm

**Label:** Canoderm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Topical on feet twice a day

**Intervention Names:**

- Drug: Oviderm

**Label:** Oviderm

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Topical on feet twice a day

**Intervention Names:**

- Drug: Decubal

**Label:** Decubal

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Canoderm

**Description:** humectant

**Name:** Canoderm

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Oviderm

**Description:** humectant + antimicrobial

**Name:** Oviderm

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Decubal

**Description:** Non-humectant

**Name:** Decubal

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)

**Measure:** Xerosis Severity

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** Trans epidermal water loss (TEWL) (grams per square meter per hour)

**Measure:** Transepidermal water loss

**Time Frame:** 4 weeks

**Description:** Skin resistance in Ohms (Ω)

**Measure:** Skin resistance

**Time Frame:** 4 weeks

**Description:** Skin Capacitance in Farads (F)

**Measure:** Skin Capacitance

**Time Frame:** 4 weeks

**Description:** Skin pH (5-8)

**Measure:** Skin pH

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
* Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
* Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.

Exclusion Criteria:

* Known sensibility to any of the ingredients in the products.
* Other diagnosed skin disease on the feet.
* Active lesions on either foot.
* Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
* Potential study subjects judged unable to comply with treatment schedule and study specific information.
* Female of childbearing potential that do not use effective medically accepted contraception.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tautgirdas.ruzgas@mau.se

**Name:** Tautgirdas Ruzgas, Professor

**Phone:** +46406657431

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Malmo University

**Name:** Christine Kumlien, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: HIGH

- As Found: Connective Tissue Diseases

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000003920

- Term: Diabetes Mellitus

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
