NCT00935051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2009

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

4.2 years

First QC Date

July 2, 2009

Last Update Submit

December 17, 2013

Conditions

Diabetic Foot Ulcer

Keywords

type 1 diabetestype 2 diabetesDiabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Picture + MMPs and TIMP1 at week 0 and week 4OTHER

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.

Arm 1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 )
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetology department

Grenoble, Isere, 38043, France

Location

Service de Diabétologie du Pr Halimi, CHU Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Matrix Metalloproteinases

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • Pierre-Yves Benhamou, PhD

    University Hospital, Grenoble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 8, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

FR(2)