Diabetic Foot UlcerNCT05772507
Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
A study testing URGO AWC_008 dressing or URGO AWC_022 dressing in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Laboratoires URGO at 1 site in France.
Trial summary
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- What is being tested?
- URGO AWC_008 dressing or URGO AWC_022 dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2023to Oct 2024
- 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
- Related to all wounds :
- Adult patient having given free, informed and written consent
- Patient affiliated to a social security insurance scheme (applicable For France),
- Inpatient or outpatient who can be followed by the same investigative team throughout the investigation,
- Acute wound (burn, traumatic wound, unstitched surgical wound) or chronic wound (leg ulcer, pressure ulcer, diabetic foot ulcer),
- Wound whose surface can be covered by a single dressing,
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- Wound at least 3 cm from any edge of another wound.
- Related to acute wounds, leg ulcer, pressure ulcer:
- Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 3 of the following clinical signs:
- Pain (spontaneous, pressure pain or increased pain),
- Peri-wound erythema,
- Oedema, induration or swelling,
- Odour (increase, change),
- Exudate (colour modification or increase of exudate),
- Local warmth,
- Hypergranulation,
- Bleeding, friable granulation tissue,
- Stagnant healing/wound deterioration.
- Related to diabetic foot ulcer :
- Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 2 of the following clinical signs:
- Pain (spontaneous, pressure pain or increased pain),
- Peri-wound erythema between 0.5-2.0 cm around the wound,
- Oedema, induration or swelling,
- Odour (increase, change),
- Exudate (colour modification or increase of exudate),
- Local warmth,
- Hypergranulation,
- Bleeding, friable granulation tissue,
- Stagnant healing/wound deterioration,
Who cannot join
- Patient with a wound for which treatment in a hyperbaric chamber is planned within 4 weeks following inclusion,
- Patient with a serious general condition, that could lead to withdrawal from the trial before four weeks of treatment,
- Patient who has experienced an acute ischaemic event (acute myocardial infarction or stroke) during the 3 months prior to inclusion in the investigation,
- Patient with a systemic infection
- Wound totally or partially covered on its surface with a black plaque of necrosis,
- Cancerous wound
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
URGO
Dijon
Clemence TUMBA, PharmD, +33 3 80 44 74 09, c.tumba@fr.urgo.com
Olivier TACCA, PhD, +33 3 80 44 74 22, o.tacca@fr.urgo.com
About this study
Official title: Assessment of the Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings in Local Management of Acute and Chronic Wounds at Risk of Local Infection or With Clinical Signs of Local Infection
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection
Read the detailed description
prospective multicenter, non comparative clinical investigation
This is a prospective multicenter, non comparative open-label, clinical investigation conducted in patients with acute and chronic wounds at risk of local infection or with clinical signs of local infection.
This study is carried out in France and Spain in around 30 investigator sites. A total of 85 patients meeting the eligibility criteria will be included. The patients will be followed for 4 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied wounds is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 1, Week 2, Week 3 and Week 4).
- Being tested
- URGO AWC_008 dressing or URGO AWC_022 dressing
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGO AWC_008 dressing or URGO AWC_022 dressingDevice
local management of acute or chronic wounds
| Study group | Role | What they receive |
|---|---|---|
| medical device under investigation | Experimental | URGO AWC_008 or URGO AWC_022 dressing. These 2 dressings are similar and only the adhesive constitutes a difference. The choice of study dressing will be left to the discretion of the investigator during the treatment of the patient, depending on the nature of the wound and the condition of the peri-wound skin. Receives: Device: URGO AWC_008 dressing or URGO AWC_022 dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative wound area reduction (RWAR)
changes in the area of wounds after 4 weeks of treatment.
Measured: 4 week treatment period
Secondary outcomes (2)
percentage of patients whose wound has healed
Complete closure of the Venous Leg Ulcer (VLU) - Healing of the wound is defined by 100% re-epithelialization of the wound
Measured: 4 week treatment period
Nature and incidence of Treatment Adverse Effects as assessed in percentage for each dressing
Safety analysis with nature and number of adverse event related to the use of the dressings (serious/ non-serious)
Measured: 4 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start22 Aug 2023
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772507
- Sponsor's protocol ID
- IDRCB no.: 2022-A00862-41
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings in Local Management of Acute and Chronic Wounds at Risk of Local Infection or With Clinical Signs of Local Infection
- ClinicalTrials.gov ID
- NCT05772507
- Acronym / sponsor ID
- IDRCB no.: 2022-A00862-41
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Mar 2023 (actual)
- 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.
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection
Detailed description
prospective multicenter, non comparative clinical investigation
This is a prospective multicenter, non comparative open-label, clinical investigation conducted in patients with acute and chronic wounds at risk of local infection or with clinical signs of local infection.
This study is carried out in France and Spain in around 30 investigator sites. A total of 85 patients meeting the eligibility criteria will be included. The patients will be followed for 4 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied wounds is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 1, Week 2, Week 3 and Week 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical device under investigation | Experimental | Device: URGO AWC_008 dressing or URGO AWC_022 dressingURGO AWC_008 or URGO AWC_022 dressing. These 2 dressings are similar and only the adhesive constitutes a difference. The choice of study dressing will be left to the discretion of the investigator during the treatment of the patient, depending on the nature of the wound and the condition of the peri-wound skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Adult patient having given free, informed and written consent
- Patient affiliated to a social security insurance scheme (applicable For France),
- Inpatient or outpatient who can be followed by the same investigative team throughout the investigation,
- Acute wound (burn, traumatic wound, unstitched surgical wound) or chronic wound (leg ulcer, pressure ulcer, diabetic foot ulcer),
- Wound whose surface can be covered by a single dressing,
Key exclusion criteria (6 listed)
- Patient with a wound for which treatment in a hyperbaric chamber is planned within 4 weeks following inclusion,
- Patient with a serious general condition, that could lead to withdrawal from the trial before four weeks of treatment,
- Patient who has experienced an acute ischaemic event (acute myocardial infarction or stroke) during the 3 months prior to inclusion in the investigation,
- Patient with a systemic infection
- Wound totally or partially covered on its surface with a black plaque of necrosis,
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 AWC_008 dressing or URGO AWC_022 dressinglocal management of acute or chronic wounds | Device | medical device under investigation |
Primary outcome
relative wound area reduction (RWAR)
Time frame: 4 week treatment period
changes in the area of wounds after 4 weeks of treatment.
2 secondary outcomes
percentage of patients whose wound has healed
Time frame: 4 week treatment period
Nature and incidence of Treatment Adverse Effects as assessed in percentage for each dressing
Time frame: 4 week treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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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.
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 AWC_008 dressing or URGO AWC_022 dressing in people with Diabetic Foot Ulcer and Venous Leg Ulcer, 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 29 inclusion and 6 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 26 Sep 2023. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative wound area reduction (RWAR) (time frame: 4 week treatment period). 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 26 Sep 2023.