Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT00935051
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2009-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2013-12
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:
DIAB-MMP2
Brief Summary:
The primary objective of this study is to assess the sensitivity and specificity of a MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow up visit.
Detailed Description:
This monocentric, prospective, non-randomized study assesses the amount of the main metalloproteinases (MMP1, MMP9, MMP13) and their inhibitor TIMP-1 in wound fluid from diabetic foot ulcers.
It aims at demonstrating whether a MMP-1/TIMP-1 ratio equal to 0.24 at study entry can predict wound healing 12 weeks later. All patients will receive the same treatment according to our local protocol. The difference with standard care will be a sample of wound fluid at week 0 and week 4 and a numeric photograph for wound area measurement at week 0, week 4 and week 12.
The main outcome measurement is the percent change of wound area between week 0 and week 12 Secondary objectives include the evaluation of a MMP-1/TIMP-1 ratio equal to 0.4 and the search for confounding factors. A correlation between MMP-9, MMP-13 and wound healing will also be investigated.
It aims at demonstrating whether a MMP-1/TIMP-1 ratio equal to 0.24 at study entry can predict wound healing 12 weeks later. All patients will receive the same treatment according to our local protocol. The difference with standard care will be a sample of wound fluid at week 0 and week 4 and a numeric photograph for wound area measurement at week 0, week 4 and week 12.
The main outcome measurement is the percent change of wound area between week 0 and week 12 Secondary objectives include the evaluation of a MMP-1/TIMP-1 ratio equal to 0.4 and the search for confounding factors. A correlation between MMP-9, MMP-13 and wound healing will also be investigated.
Study Oversight
Has Oversight DMC:
False
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?: