Physiotulle vs Urgotul in the Treatment of Leg Ulcer
This study has been completed.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01238419
First received: October 27, 2010
Last updated: September 2, 2011
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leg Ulcers |
Device: Physiotulle Device: URGOTUL |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer |
Resource links provided by NLM:
Further study details as provided by Coloplast A/S:
Primary Outcome Measures:
- pain at dressing removal [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 188 |
| Study Start Date: | November 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Physiotulle |
Device: Physiotulle
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
|
| Placebo Comparator: Urgotul |
Device: URGOTUL
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238419
Locations
| Denmark | |
| Bispebjerg ^Hospital | |
| Bispebjerg, NV, Denmark, 2400 | |
| Arhus Sygehus | |
| Arhus, Denmark, 8000 | |
| Odense Universitets Hospital | |
| Odense, Denmark, 5000 | |
| France | |
| Cabilet Medical | |
| Abbeville, France, 80100 | |
| CHU Sud | |
| Amiens, France, 80054 | |
| Cabinet Medical | |
| Angouleme, France, 16000 | |
| Centre Hospitalier | |
| Arras, France, 62022 | |
| Cabinet Médical | |
| Bagnoles de L'Orne, France, 61140 | |
| CHU | |
| Brest, France, 29609 | |
| CHU | |
| Caen, France, 14033 | |
| Hôpital Manchester | |
| Charlevilles Mézières, France, 80011 | |
| Centre Hospitalier de Douai | |
| Douai, France, 59507 | |
| CHIVA | |
| Foix, France, 09000 | |
| Hôpital de Freyming | |
| Freyming Merleback, France, 57804 | |
| Centre Hospitalier | |
| Haguenau, France, 67504 | |
| Hôpital Corention Celton | |
| Issy les Moulineaux, France, 92133 | |
| CHD Les Oudairies | |
| La Roche sur Yon, France, 85925 | |
| CH Le Mans | |
| Le Mans, France, 72000 | |
| Cabinet Medical | |
| Lille, France, 59000 | |
| Hôpital Dupuytren | |
| Limoges, France, 87042 | |
| Cabinet Médical | |
| Luneville, France, 54300 | |
| Hôpital jacques Monod | |
| Montivilliers, France, 76290 | |
| CHU Caremeau | |
| Nimes, France, 30900 | |
| Hôpital lariboisiere | |
| Paris, France, 75475 | |
| CHRU La Miletrie | |
| Poitiers, France, 86021 | |
| CH Cornouailles | |
| Quimper, France, 29107 | |
| Clinique Mathilde | |
| Rouen, France, 76175 | |
| Hôpital de Saint Gaudens | |
| Saint Gaudens, France, 31806 | |
| Centre hospitalier intercommunal | |
| Saint Germain en Laye, France, 78105 | |
| Cabinet Medical | |
| Sarrebourg, France, 57400 | |
| HIA Sainte Anne | |
| Toulon, France, 83000 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| CHRU Tours | |
| Tours, France, 37044 | |
| CH | |
| Valenciennes, France, 59322 | |
Sponsors and Collaborators
Coloplast A/S
More Information
No publications provided
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT01238419 History of Changes |
| Other Study ID Numbers: | FR010WS |
| Study First Received: | October 27, 2010 |
| Last Updated: | September 2, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Skin Ulcer Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013