Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011110
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2021-08-11
Brief Title:
Evaluating the Ease of Application Removal and Comfort of Gradusox
Sponsor:
The Whiteley Clinic
Organization:
The Whiteley Clinic
Study Overview
Official Title:
Prospective Assessment to Evaluate the Ease of Application and Removal of GraduSOX VLU Kit Compared to Sigvaris Ulcer X VLU Kit and Comfort in Use by Healthy Patients Who Have Completed Venous Treatment
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
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:
The aims of this study are to evaluate the comfort and ease of application and removal of GraduSOX compression stockings compared to standard compression stockings of the same compression class
Detailed Description:
After being informed about the study all participants giving written informed consent will be randomised by closed envelope randomisation to either a GraduSOX on their right leg and Sigvaris on their left leg or b Sigvaris on their right leg and GraduSOX on their left leg At Day 1 participants will attend the clinic and be fitted with their stockings and given an Evaluation Form The Evaluation Form has four sections to be completed on Day 1 Day 2 Day 4 and Day 8 of the study Each section asks multiple choice questions related to the comfort and ease of applying and removing each stocking
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?:
False
Is an FDA AA801 Violation?:
None