Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-18 @ 8:27 AM
Study NCT ID:
NCT06143215
Status:
None
Last Update Posted:
2025-03-19 00:00:00
First Post:
2023-11-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial
Status:
None
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:
Diatime
Brief Summary:
The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission.
There will exist three different groups for analyses after randomization:
* Group 1: patients revised every fourweeks.
* Group 2: patients revised every eightweeks.
* Group 3: patients revised every twelveweeks.
Main outcome measure will include:
\- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.
Secondary outcome measure will include:
* Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
* Minor amputations: evaluated in a monthly basis during the 1-year prospective period
Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.
There will exist three different groups for analyses after randomization:
* Group 1: patients revised every fourweeks.
* Group 2: patients revised every eightweeks.
* Group 3: patients revised every twelveweeks.
Main outcome measure will include:
\- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.
Secondary outcome measure will include:
* Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
* Minor amputations: evaluated in a monthly basis during the 1-year prospective period
Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: