Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-03
Brief Title:
Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes
Sponsor:
Malmö University
Organization:
Malmö University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None