Diabetic Foot Ulcer(s)NCT01717183
Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers
A study testing Urgo 310 3113 in people with Diabetic Foot Ulcer(s), run by Laboratoires URGO at 1 site in France.
Trial summary
The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer(s)
- What is being tested?
- Urgo 310 3113
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Apr 2013to not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years old who has provided his/her written informed consent
- Patient covered by the French national insurance system
- Patient with Type 1 or Type 2 diabetes mellitus with glycated hemoglobi(HbA1c) levels ≤ 10% (assayed in the previous 3 months. If not available, this assay must be performed during the run-in period)
- Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study
- Patient who agrees to wear the prescribed off-loading system every day, associated with the test dressing
- DFU with adequate arterial blood supply in the target limb DFU grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification
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- Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament)
- DFU located on the toe or on the lateral, dorsal or plantar side of the foot
- Target DFU surface area between 1 cm² and 30 cm², following debridement DFU duration between 1 and 24 months
- No local clinical infection (as defined by IDSA/IWGDF criteria) for any wound (target DFU or not) on lower limbs
- DFU adequately debrided
Who cannot join
- Pregnant or breast-feeding woman or woman of childbearing potential not using effective means of contraception
- Patient who took part in another clinical trial in the previous month or who is to take part in another clinical trial in the 20 weeks following inclusion
- Patient with any known intolerance or allergy or reported adverse reaction to one of the components of the trial dressings
- Patient who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) in the previous 2 months
- Patient who has presented an acute ischemic event (Acute Myocardial Infarction (AMI) or stroke) in the 3 months before inclusion
- Patient with Severe kidney failure, defined as requirement for dialysis
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- Patient with a systemic infection not controlled by suitable antibiotic treatment
- Patient with known osteomyelitis
- Patient with leg ulcer(s), regardless of limb
- Patient with wounds other than the target DFU located on the heel or on the interdigital part of the foot
- Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents
- Patient treated for a chronic disease requiring high doses of systemic corticosteroids (≥ 40 mg.d-1 of prednisolone or equivalent)
- Patient with a severe illness that might lead to premature withdrawal from the trial
- DFU for which surgery or surgical revascularization is planned at any time during the study
- Deep DFU defined as stage III or IV (University of Texas Diabetic Wound Classification)
- DFU clinically infected as defined by IDSA/IWGDF criteria
- DFU with more than 20% of its surface area covered by black necrotic tissue following debridement
- DFU located on an amputation stump
- DFU with neoplastic component
Trial locations and contacts
1 site in 1 country.
Jacques MARTINI, MD contact
About this study
Official title: Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial
The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
- Conditions
- Diabetic Foot Ulcer(s)
- Being tested
- Urgo 310 3113, Placebo URGO 310 3113 dressing
- Keywords
- Patient
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgo 310 3113Device
URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition
Placebo URGO 310 3113 dressingDevice
| Study group | Role | What they receive |
|---|---|---|
| URGO 310 3113 dressing - new | Experimental | flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. Receives: Device: Urgo 310 3113 |
| URGO 310 3113 dressing | Placebo comparator | flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. Receives: Device: Placebo URGO 310 3113 dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of complete wound closure
Secondary outcomes (2)
Time to complete wound closure
Change in wound surface area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer(s)Studies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717183
- Sponsor's protocol ID
- FI-12-05-310 3113
- Status last verified
- Apr 2014
- First submitted
- 26 Oct 2012
- Last updated
- 11 Apr 2014
- Results posted
- No
Publications
Maunoury F, Oury A, Fortin S, Thomassin L, Bohbot S; Explorer Study. Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One. 2021 Jan 22;16(1):e0245652. doi: 10.1371/journal.pone.0245652. eCollection 2021.
PubMed 33481840Edmonds M, Lazaro-Martinez JL, Alfayate-Garcia JM, Martini J, Petit JM, Rayman G, Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196. doi: 10.1016/S2213-8587(17)30438-2. Epub 2017 Dec 20.
PubMed 29275068
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT01717183
- Acronym / sponsor ID
- FI-12-05-310 3113
- Conditions
- Diabetic Foot Ulcer(s)
- Keywords
- Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- First posted
- 30 Oct 2012 (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 main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URGO 310 3113 dressing - new | Experimental | Device: Urgo 310 3113flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. |
| URGO 310 3113 dressing | Placebo comparator | Device: Placebo URGO 310 3113 dressingflexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female over 18 years old who has provided his/her written informed consent
- Patient covered by the French national insurance system
- Patient with Type 1 or Type 2 diabetes mellitus with glycated hemoglobi(HbA1c) levels ≤ 10% (assayed in the previous 3 months. If not available, this assay must be performed during the run-in period)
- Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study
- Patient who agrees to wear the prescribed off-loading system every day, associated with the test dressing
Key exclusion criteria (19 listed)
- Pregnant or breast-feeding woman or woman of childbearing potential not using effective means of contraception
- Patient who took part in another clinical trial in the previous month or who is to take part in another clinical trial in the 20 weeks following inclusion
- Patient with any known intolerance or allergy or reported adverse reaction to one of the components of the trial dressings
- Patient who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) in the previous 2 months
- Patient who has presented an acute ischemic event (Acute Myocardial Infarction (AMI) or stroke) in the 3 months before inclusion
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 |
|---|---|---|
| Urgo 310 3113URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition | Device | URGO 310 3113 dressing - new |
| Placebo URGO 310 3113 dressing | Device | URGO 310 3113 dressing |
Primary outcome
Percentage of complete wound closure
2 secondary outcomes
Time to complete wound closure
Change in wound surface area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Derived from this study: PubMed 33481840Maunoury F, Oury A, Fortin S, Thomassin L, Bohbot S; Explorer Study. Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One. 2021 Jan 22;16(1):e0245652. doi: 10.1371/journal.pone.0245652. eCollection 2021.
- Derived from this study: PubMed 29275068Edmonds M, Lazaro-Martinez JL, Alfayate-Garcia JM, Martini J, Petit JM, Rayman G, Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196. doi: 10.1016/S2213-8587(17)30438-2. Epub 2017 Dec 20.
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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.
Jacques MARTINI, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgo 310 3113 in people with Diabetic Foot Ulcer(s), run by Laboratoires URGO at 1 site 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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques MARTINI, MD (00 33 5 61 32 32 89), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of complete wound closure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717183, which also lists 2 linked publications.
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 11 Apr 2014.