Leg UlcersPhase 4NCT01238419
Physiotulle vs Urgotul in the Treatment of Leg Ulcer
A Phase 4 study testing Physiotulle and URGOTUL in people with Leg Ulcers, run by Coloplast A/S at 34 sites in 2 countries.
Trial summary
The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers
- What is being tested?
- Physiotulle and URGOTUL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Nov 2009to May 2011
- Phase
- Phase 4
- 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
- Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
- Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
- Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue > 70 %)
- Patient with venous or predominantly venous leg ulcer with low exsudate
- Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
- Patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion
- Patient available to be monitored for at least 4 weeks
- Patient able to answer questionnaires and particularly to evaluate his pain
Who cannot join
- Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection *)* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
- Patient requiring an analgesic treatment for the care (before dressing removal)
- Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
- Patient with arterial ulcer
- Patient with purely traumatic, infectious or neoplastic origin ulcer
- Patient with a diabetic neuropathy of lower limbs
Show all 11Show fewer
- Patient with a known allergy to one of Physiotulle or Urgotul components
- Patient already participating in another clinical study
- Pregnant or breastfeeding patient
- Patient who have been taking corticoids > 10mg / day or cytostatics by systematic way for the three months prior to inclusion
- Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
France31 sites
Cabilet Medical
Abbeville, 80100
CHU Sud
Amiens, 80054
Cabinet Medical
Angoulême, 16000
Centre Hospitalier
Arras, 62022
Cabinet Médical
Bagnoles-de-l'Orne, 61140
CHU
Brest, 29609
CHU
Caen, 14033
Hôpital Manchester
Charlevilles Mézières, 80011
Centre Hospitalier de Douai
Douai, 59507
CHIVA
Foix, 09000
Hôpital de Freyming
Freyming Merleback, 57804
Centre Hospitalier
Haguenau, 67504
Hôpital Corention Celton
Issy-les-Moulineaux, 92133
CHD Les Oudairies
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans, 72000
Cabinet Medical
Lille, 59000
Hôpital Dupuytren
Limoges, 87042
Cabinet Médical
Lunéville, 54300
Hôpital jacques Monod
Montivilliers, 76290
CHU Caremeau
Nîmes, 30900
Hôpital lariboisiere
Paris, 75475
CHRU La Miletrie
Poitiers, 86021
CH Cornouailles
Quimper, 29107
Clinique Mathilde
Rouen, 76175
Hôpital de Saint Gaudens
Saint-Gaudens, 31806
Centre hospitalier intercommunal
Saint-Germain-en-Laye, 78105
Cabinet Medical
Sarrebourg, 57400
HIA Sainte Anne
Toulon, 83000
Clinique Pasteur
Toulouse, 31076
CHRU Tours
Tours, 37044
CH
Valenciennes, 59322
Denmark3 sites
Arhus Sygehus
Aarhus, 8000
Bispebjerg ^Hospital
Bispebjerg, NV, 2400
Odense Universitets Hospital
Odense, 5000
About this study
Official title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.
- Conditions
- Leg Ulcers
- Being tested
- Physiotulle, URGOTUL
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotulleDevice
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
URGOTULDevice
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
| Study group | Role | What they receive |
|---|---|---|
| Physiotulle | Experimental | Not described Receives: Device: Physiotulle |
| Urgotul | Placebo comparator | Not described Receives: Device: URGOTUL |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain at dressing removal
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
Measured: 4 weeks
Secondary outcomes (2)
Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion
Measured: 4weeks
Number of patients with adverse events as a measure of safety and tolerability
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 posted10 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238419
- Sponsor's protocol ID
- FR010WS
- Status last verified
- Oct 2010
- First submitted
- 27 Oct 2010
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
- ClinicalTrials.gov ID
- NCT01238419
- Acronym / sponsor ID
- FR010WS
- Conditions
- Leg Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Nov 2010 (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 aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotulle | Experimental | Device: Physiotulle |
| Urgotul | Placebo comparator | Device: URGOTUL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
- Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
- Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue > 70 %)
- Patient with venous or predominantly venous leg ulcer with low exsudate
- Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
Key exclusion criteria (11 listed)
- Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection *)* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
- Patient requiring an analgesic treatment for the care (before dressing removal)
- Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
- Patient with arterial ulcer
- Patient with purely traumatic, infectious or neoplastic origin ulcer
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 |
|---|---|---|
| PhysiotullePhysiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline | Device | Physiotulle |
| URGOTULUrgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix | Device | Urgotul |
Primary outcome
pain at dressing removal
Time frame: 4 weeks
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
2 secondary outcomes
Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion
Time frame: 4weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 4 weeks
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 5 Sep 2011.
Related trials for Leg Ulcers
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
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physiotulle and URGOTUL in people with Leg Ulcers, run by Coloplast A/S at 34 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pain at dressing removal (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 5 Sep 2011.