DIAB-MMP2
Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
Sponsor study identifier
interventional
59
1 country
2
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2, 2009
Actual (reported)July 8, 2009
Actual (reported)July 2013
Actual (reported)November 2013
Actual (reported)MMP-1/TIMP-1 ratio at Week 0 assessed by ELISA and percent change in wound area of diabetic foot ulcer between week 0, week 4 and week 12
Week 0, week 4 and week 12
Evaluation of a MMP-1/TIMP-1 ratio = 0.4 at Week 0 as a predictor of wound healing at week 12
Week 0, week 4 and week 12
Recognized clinical prognostic factors such as wound duration, wound area, wound depth and other possible confounding factors affecting the validity of the MMP-1/TIMP-1 ratio
Week 0 to Week 12
Correlation between MMP9, MMP13, MMP9/TIMP1 and MMP13/ TIMP1 ratios and wound healing expressed by the percent change in wound area between week 0, week 4 and week 12.
Week 0 and week 4
There is only one group of patients. Thus there is only one arm. Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4. A numeric photograph of the wound will be taken at week 0, week 4 and week 12.
Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4. This will allow to assess the level of MMP9, MMP13, MMP1 and TIMP1. A numeric photograph of the wound will be taken at week 0, week 4 and week 12 in order to assess wound area.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Diabetology department
Grenoble, Isere, 38043, France
Service de Diabétologie du Pr Halimi, CHU Grenoble
Grenoble, 38043, France
Pierre-Yves Benhamou, PhD
University Hospital, Grenoble
59 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2009
First Posted
July 8, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
December 18, 2013
Record last verified: 2013-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: