WoundHEALNCT03640871
HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer
A study testing URGO AWC_019 dressing (AWC=Advanced Wound Care) in people with Wound, run by Laboratoires URGO.
Trial summary
Assessment of efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Wound
- What is being tested?
- URGO AWC_019 dressing (AWC=Advanced Wound Care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Nov 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Related to every wounds types:
- Patient over 18 years old who has provided his/her written informed consent
- Patient affiliated to the French Social insurance
- Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- Acute wound (postoperative non-cavitary and non-sutured wound, superficial, middle or deep second degree burn, dermabrasion) or chronic wound (venous or mixed leg ulcer, pressure ulcer) or epidermolysis bullosa skin lesion
- Use of a contact layer as a primary dressing justified by the wound
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- Related to leg ulcer:
- Venous leg ulcer or mixed leg ulcer, i.e. with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3, (0.7≤ABPI≤ 1.3)
- Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing
- Related to pressure ulcer:
- Stage 2, 3 according to the EPUAP (European Pressure Ulcer Advisory Panel) classification system
- Wound on the pelvis (trochanter, ischio or sacrum) or on the heel
Who cannot join
- Patient under authorship or guardianship
- Woman of child-bearing potential who has no effective contraception method
- Pregnant or breastfeeding woman
- Patient taking part in another clinical trial
- Patient with a known allergy to carboxymethylcellulose (hydrocolloid),
- Patient with a severe illness that might lead to the premature discontinuation of the trial before the 4 weeks of treatment
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- Wound requiring surgical treatment or for which surgery is scheduled during the 4 weeks after inclusion
- Patient with an evolving neoplasia condition, treated by radiotherapy, chemotherapy or hormone therapy
- Malignant wound
- Patient with a systemic infection not controlled by suitable antibiotic treatment,
- Wound which is clinically infected
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Efficacy, Tolerance and Acceptability for the Wound Dressing URGO AWC_019 in the Local Treatment of Acute Wounds, Chronic Wounds and Epidermolysis Bullosa Skin Lesions
Assessment of efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
Read the detailed description
Non-comparative clinical study, conducted in France, to evaluate efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
- Conditions
- Wound
- Being tested
- URGO AWC_019 dressing (AWC=Advanced Wound Care)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGO AWC_019 dressing (AWC=Advanced Wound Care)Device
URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)
| Study group | Role | What they receive |
|---|---|---|
| URGO AWC_019 dressing (AWC=Advanced Wound Care) | Experimental | URGO AWC_019 dressing (AWC=Advanced Wound Care) Receives: Device: URGO AWC_019 dressing (AWC=Advanced Wound Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative evolution of the wound surface (in %) at week 4
Relative evolution of the wound surface (in %) at week 4
Measured: 4 weeks
Secondary outcomes (4)
- Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)
- Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)
Measured: 4 weeks
- Wound dressing safety (occurrence of adverse events)
- Wound dressing safety (occurrence of adverse events)
Measured: 4 weeks
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
Measured: 4 weeks
- Wound healing time (in days)
- Wound healing time (in days)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- 80 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
- NCT03640871
- Sponsor's protocol ID
- F-18-06-AWC019
- Acronym
- HEAL
- Status last verified
- Jul 2018
- First submitted
- 3 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy, Tolerance and Acceptability for the Wound Dressing URGO AWC_019 in the Local Treatment of Acute Wounds, Chronic Wounds and Epidermolysis Bullosa Skin Lesions
- ClinicalTrials.gov ID
- NCT03640871
- Acronym / sponsor ID
- HEAL / F-18-06-AWC019
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 21 Aug 2018 (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.
Assessment of efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
Detailed description
Non-comparative clinical study, conducted in France, to evaluate efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| URGO AWC_019 dressing (AWC=Advanced Wound Care) | Experimental | Device: URGO AWC_019 dressing (AWC=Advanced Wound Care)URGO AWC_019 dressing (AWC=Advanced Wound Care) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Related to every wounds types:
- Patient over 18 years old who has provided his/her written informed consent
- Patient affiliated to the French Social insurance
- Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- Acute wound (postoperative non-cavitary and non-sutured wound, superficial, middle or deep second degree burn, dermabrasion) or chronic wound (venous or mixed leg ulcer, pressure ulcer) or epidermolysis bullosa skin lesion
Key exclusion criteria (11 listed)
- Patient under authorship or guardianship
- Woman of child-bearing potential who has no effective contraception method
- Pregnant or breastfeeding woman
- Patient taking part in another clinical trial
- Patient with a known allergy to carboxymethylcellulose (hydrocolloid),
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_019 dressing (AWC=Advanced Wound Care)URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care) | Device | URGO AWC_019 dressing (AWC=Advanced Wound Care) |
Primary outcome
Relative evolution of the wound surface (in %) at week 4
Time frame: 4 weeks
Relative evolution of the wound surface (in %) at week 4
4 secondary outcomes
- Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)
Time frame: 4 weeks
- Wound dressing safety (occurrence of adverse events)
Time frame: 4 weeks
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
Time frame: 4 weeks
- Wound healing time (in days)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing URGO AWC_019 dressing (AWC=Advanced Wound Care) in people with Wound, run by Laboratoires URGO.
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 12 inclusion and 11 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Clémence Ms Tumba, PharmD (++33380447409, c.tumba@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative evolution of the wound surface (in %) at week 4 (time frame: 4 weeks). 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 22 Aug 2018.