Diabetic Foot UlcerEarly Phase 1DIAB-MMP2NCT00935051
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
A Early Phase 1 study testing Picture + MMPs and TIMP1 at week 0 and week 4 in people with Diabetic Foot Ulcer, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Picture + MMPs and TIMP1 at week 0 and week 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesFrance
- Study dates
- May 2009to Nov 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Diabetology department
Grenoble, Isere, 38043
Service de Diabétologie du Pr Halimi, CHU Grenoble
Grenoble, 38043
About this study
Official title: Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Picture + MMPs and TIMP1 at week 0 and week 4
- Keywords
- type 1 diabetes, type 2 diabetes, Diabetic foot ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Picture + MMPs and TIMP1 at week 0 and week 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Week 0 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Benhamou, PhD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935051
- Sponsor's protocol ID
- 2008-A00155-50
- Acronym
- DIAB-MMP2
- Status last verified
- Dec 2013
- First submitted
- 2 Jul 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00935051
- Acronym / sponsor ID
- DIAB-MMP2 / 2008-A00155-50
- Conditions
- Diabetic Foot Ulcer
- Keywords
- type 1 diabetes, type 2 diabetes, Diabetic foot ulcer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Picture + MMPs and TIMP1 at week 0 and week 4There 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picture + MMPs and TIMP1 at week 0 and week 4Sample 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. | Other | Arm 1 |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Benhamou, PhD study director
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Picture + MMPs and TIMP1 at week 0 and week 4 in people with Diabetic Foot Ulcer, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.