Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.

Varicose Ulcer Clinical Trial

Official title:

Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449422
• Other study ID #: FI-11-02-310 3082
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2011
• Last updated: March 28, 2013
• Start date: May 2011

Study information

• Verified date: March 2013
• Source: Laboratoires URGO
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des MédecinsGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old who has provided his/her written informed consent

• Patient who can be monitored by the same investigation team throughout the duration of the study

• Patient who agrees to wear effective venous compression every day, associated with the trial dressing

• Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3

• Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2

• Ulcer duration between 3 and 36 months

• Ulcer where the surface area is 70% or more covered by fibrinous tissue

• Ulcer at least 3 cm away from any other lesion

• Ulcer moderately or strongly exudative justifying the use of an absorbent dressing

Exclusion Criteria:

• Female patient of child-bearing potential who has no effective means of contraception

• Patient who is pregnant or breastfeeding

• Patient taking part in another therapeutic trial

• Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)

• Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment

• Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy

• Patient with a systemic infection not controlled by suitable antibiotic treatment

• Patient who, during the 3 months before inclusion, presented a deep vein thrombosis

• Ulcer where its surface is totally or partially covered by black necrotic plaque

• Ulcer which is clinically infected

• Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion

• Malignant ulcer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

Device:
• Dressing
the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
• Dressing
the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days.

Locations

Country	Name	City	State
France	Hopital Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.	The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements: Regression of the area (%) = [(ST0-STlast)/ST0] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available	Week 1, 2, 4 and 6	No
Secondary	Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks.		Week 1, 2, 4 and 6	No
Secondary	Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation		Week 1, 2, 4 and 6	No
Secondary	Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm)		Week 1, 2, 4 and 6	No
Secondary	Comparison between the 2 groups of the percentage of wound care associated with manual debridement		Week 1, 2, 4 and 6	No
Secondary	Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5D™ questionnaire		Week 1, 2, 4 and 6	No
Secondary	Comparison between the 2 groups of the percentage of the participants number with Adverse Events		Week 1, 2, 4 and 6	Yes
Secondary	Comparison between the 2 groups of the mean number of dressing changes per week.		Week 1, 2, 4 and 6	No
Secondary	Comparison between the 2 groups of the easiness application and removal		Week 1, 2, 4 and 6	No
Secondary	Comparison between the 2 groups of the percentage of good or very good conformability		Week 1, 2, 4 and 6	No
Secondary	Comparison between the 2 groups of the mean value for overall performance score	This score will be between 0 and 36	Week 1, 2, 4 and 6	No