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.

NCT01449422 | Completed Phase 4

• 1 other identifier: FI-11-02-310 3082
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicose Ulcer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

• 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

• 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

• Comparison between the 2 groups of the percentage of wound care associated with manual debridement

  Week 1, 2, 4 and 6

• 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

Study Arms (2)

URGO 310 3082

EXPERIMENTAL

Device: Dressing

Aquacel

ACTIVE COMPARATOR

Device: Dressing

Interventions

Dressing DEVICE

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).

URGO 310 3082

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ulcer where its surface is totally or partially covered by black necrotic plaque
• Ulcer which is clinically infected
• Malignant ulcer

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

Hopital Rothschild

Paris, 75012, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 10, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

FR (1)