Comparison of creams for the treatment of dry foot of persons with diabetes.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Malmö Universitet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2023-07-31

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Knowledge foundation, profile “Biobarriers – health, disorders and healing”, #20190010 · Malmö university, research platform “Healing and prevention of diabetic foot ulcers”

External identifiers

EU CT number

2022-500907-27-01

WHO UTN

U1111-1287-9638

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.

Secondary objectives 1

1. Secondary objectives: (i) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (ii) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (iii) Safety: documentation and evaluation of adverse effects and assessing vital signs.

Conditions and MedDRA coding

xerotic skin on foot of subjects with diabetes

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Persons with a physician’s diagnosis of Diabetes Mellitus with self-experienced dry skin.
2. Dry skin on both feet with a XSS score on both feet between 2 and 6, with not more than 1 score unit in difference between the subject´s right and left foot.
3. Age ≥ 18 years.
4. Ability of the subject to understand and complete the necessary forms.
5. Sufficient knowledge in the Swedish language to understand the meaning and procedure of the study as judged by the investigator.

Exclusion criteria 7

1. Known sensibility to any of the study products and their ingredients.
2. Other diagnosed skin disease than dry skin on the feet.
3. Active lesions on either foot.
4. Other severe disease which might counteract or influence the study aims.
5. Treatment with systemic or locally acting medications, including topical moisturizers or keratolytic agents on the feet which might counteract or influence the study aims, within two weeks before the beginning of the study.
6. Persons judged unable to comply with treatment schedule and study specific information.
7. Female of childbearing potential who does not agree to use effective medically accepted contraception according to “Antikonception, behandlingsrekommendation. Information från Läkemedelsverket 2:2014”.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.

Secondary endpoints 1

1. (1) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (2) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (3) Safety: Documentation and evaluation of adverse effects and assessing vital signs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Malmö Universitet

Sponsor organisation

Malmö Universitet

Address

Bassanggatan 2, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 19

Country

Sweden

Scientific contact point

Organisation

Malmö Universitet

Contact name

Tautgirdas Ruzgas

Public contact point

Organisation

Malmö Universitet

Contact name

Christine Kumlien

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications