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Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers (DIAB-MMP2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00935051
First received: July 2, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
Other: Picture + MMPs and TIMP1 at week 0 and week 4
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 0, week 4 and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of a MMP-1/TIMP-1 ratio = 0.4 at Week 0 as a predictor of wound healing at week 12 [ Time Frame: Week 0, week 4 and week 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 0 to Week 12 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Week 0 and week 4 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: May 2009
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
Other: Picture + MMPs and TIMP1 at week 0 and week 4
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 1 or type 2 diabetes
  • Age over 40
  • Chronic diabetic foot ulcer (duration over 30 days)
  • Grade 1 to 3, stage A and C according to the University of Texas Wound Classification, except stage B and D
  • Wound area over 0.5 cm²
  • Social Security membership or benefit from Social Security
  • Informed consent, with a signed and approved form
  • Possibility to have clinical follow-up and compliance during 3 months

Exclusion Criteria:

  • Urgent need for locoregional surgery
  • Clinical criteria for infection, defined by the presence of pus or/and at least 2 local signs among the following: heat, erythema, lymphangitis, lymphadenopathy, oedema, pain
  • Other pathology that could interfere with the healing process (vasculitis, connectivitis, dysimmunity, immunosuppressive treatment or corticoids, ongoing radiotherapy or chemotherapy )
  • Any severe pathology that would constitute a contra-indication to the patient's inclusion
  • Ongoing therapeutic research protocol
  • Underage patient, major patient under guardianship or protected by the Law
  • Pregnant, parturient or breastfeeding woman
  • Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935051

Locations
France
Diabetology department
Grenoble, Isere, France, 38043
Service de Diabétologie du Pr Halimi, CHU Grenoble
Grenoble Cedex 9, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Study Director: Pierre-Yves Benhamou, PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00935051     History of Changes
Other Study ID Numbers: 2008-A00155-50
Study First Received: July 2, 2009
Last Updated: December 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
type 1 diabetes
type 2 diabetes
Diabetic foot ulcer

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Matrix Metalloproteinase Inhibitors
TIMP1 protein, human
Tissue Inhibitor of Metalloproteinase-1
Tissue Inhibitor of Metalloproteinases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014