Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143215
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-11-10
Brief Title:
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons With Diabetes and Remission
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
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:
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:
Diatime
Brief Summary:
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration patients in remission The literature suggests to clinically check the patients in a 4-6 weeks basis despite this this recommendation is based in expert opinions
The main question it aims to answer is
- Does different revision times could affect the reulceration rate in persons with diabetes in remission Different revision time will be 2 weeks 4 weeks and 6 weeks
The main question it aims to answer is
- Does different revision times could affect the reulceration rate in persons with diabetes in remission Different revision time will be 2 weeks 4 weeks and 6 weeks
Detailed Description:
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 two weeks
Group 2 patients revised every four weeks
Group 3 patients revised every six weeks
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 two weeks
Group 2 patients revised every four weeks
Group 3 patients revised every six weeks
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
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